Methods and devices for fastening bulging or herniated intervertebral discs

ABSTRACT

Methods and apparatuses for compressing and holding a bulging or herniated intervertebral disc. A number of fastener embodiments are disclosed, including a resiliently curved fastener, suture, screw, staple, tack and others. The curved fastener is resiliently straightened and loaded into a needle for delivery and deployment. In the intervertebral disc, the deployed fastener resumes the curvature to grip and hold the bulge. Alternatively, the suture is anchored and used to tie down the bulging tissue. The screw, staple or tack can also be used to securely fasten, compress and hold the bulge from impinging upon adjacent nerves or tissues.

CROSS REFERENCE TO OTHER APPLICATIONS

This application is a national stage application claiming priority ofWIPO application number PCT/US99/21138, which claimed the benefit ofU.S. Provisional Application No. 60/114,545 filed on Dec. 31, 1998, byTeresa T. Yeung.

FIELD OF THE INVENTION

The invention relates to methods and devices for fastening bulging orherniated discs. More particularly, the invention relates to devices forcompressing the bulge or herniation of a damage intervertebral disc.

BACKGROUND, TRADITIONAL SURGICAL PRACTICES AND PRIOR INVENTIONS

In recent years, much attention has been given to controlling surgicalcosts. One of the cost-effective approaches is to accelerate the speedof recovery and shorten post-surgical hospital stays. In addition tolowering costs, for the comfort and safety of patients, minimallyinvasive or endoscopic surgeries are becoming more and more popular. Theterm “endoscopic” used in this invention encompasses arthroscopic,laparoscopic, hysteroscopic and other instrument viewing procedures.Endoscopy is a surgical procedure, which allows surgeons to manipulateinstruments to view and operate the surgical sites through smallincisions in the bodies of patients.

(A) Meniscal Tear

In order to minimize both the patients' trauma and potential damage tonerves, blood vessels and other tissues, it is clearly desirable tominimize the size and number of holes puncturing the patients. Takemeniscal repair in the knee for example, the current arthroscopicprocedure requires one hole for the arthroscope, one hole for a needleto deliver a suture and another hole for a suture-retrieving instrumentto complete one suture stitch (Arthroscopic Surgery by L. Johnson, M.D.;Knee Surgery by F. Fu, MD, et al.; Traumatic Disorders of the Knee by J.Siliski, MD; and Knee Surgery Current Practice by P. Aichroth, FRCS etal.). A minimum of three holes is made for the arthroscopic repair. Insome cases, surgeons also require a distractor, an external fixationdevice that is screwed in through skin to the bones, separating thefemur from the tibia. This expands the knee joint and makes room tomanipulate both the suture and the suture-retrieving instrument. Due tothe tightness of joint space, often a needle or instrument canaccidentally scrape and damage the smooth surface of the jointcartilage, which given time, can potentially lead to osteoarthritisyears after the surgery.

Recently, instead of delivering, manipulating and retrieving a suture,often in a very tight surgical site, delivery of tacks with barbs (U.S.Pat. No. 5,702,462 to Oberlander, 1997; U.S. Pat. No. 5,398,861 toGreen, 1995; U.S. Pat. No. 5,059,206 to Winters, 1991; U.S. Pat. No.4,895,148 to Bays et. al., 1990; U.S. Pat. No. 4,884,572 to Bays et.al., 1989), staples (U.S. Pat. No. 5,643,319 to Green et. al., 1997) andfasteners (U.S. Pat. No. 5,843,084 to Hart et. al., 1998; U.S. Pat. No.5,374,268 to Sander, 1994; U.S. Pat. No. 5,154,189 to Oberlander et.al., 1992) through a small opening to hold torn tissue, such as themeniscus, in place have been implemented. Unfortunately, very few, ifany, of these tacks, staples and fasteners have the holding strength tomeet the standard set by sutures.

During the insertion of these devices into tissues, the barbs carvetheir way into their final holding position. Unavoidably, the carvingdamages the tissue, and thus weakens it thereby decreasing the holdingstrength of the freshly inserted devices. As tension is applied to thefastened tissue, it is not surprising that the barbs can lose theirgrip, slip and creep along the carved paths created during insertion,leaving gaps in the supposed closure sites. The creeping problem offastening devices is particularly evident in slow healing tissues, suchas menisci, and also in tissues providing high tensile strength, such asligaments and tendons. Since gaps are present, the torn tissue does notreattach and heal, even with the passage of time.

Non-biodegrdable fasteners often have the problem of device migration,which can be devastating, especially into nerves, joints or vessels,after numerous cycles of tissue remodeling.

In summary, currently most of the tacks or fasteners have one or more ofthe following drawbacks: (1) weak holding strength, (2) creeping andleaving gaps in the repair site, and (3) potential migration intosensitive tissues.

Numerous staples (U.S. Pat. No. 5,829,662 to Allen et. al., 1998; U.S.Pat. No. 5,826,777 to Green et. al., 1998; U.S. Pat. No. 5,817,109 toMcGarry et. al., 1998; U.S. Pat. No. 5,794,834 to Hamblin et. al., 1998;U.S. Pat. No. 5,715,987 to Kelley et. al., 1998; U.S. Pat. No. 5,662,662to Bishop et. al., 1997; U.S. Pat. No. 5,413,584 to Schulze, 1995; U.S.Pat. No. 5,333,772 to Rothfuss et. al., 1994; U.S. Pat. No. 5,304,204 toBregen, 1994; U.S. Pat. No. 5,257,713 to Green et. al., 1993; U.S. Pat.No. 5,089,009 to Green, 1992; U.S. Pat. No. 5,002,563 to Pyka et. al.,1991; U.S. Pat. No. 4,944,295 to Gwathmey, 1990; U.S. Pat. No. 4,671,279to Hill, 1987; U.S. Pat. No. 4,485,816 to Krumme, 1984; U.S. Pat. No.4,396,139 to Hall et. al., 1983) are designed and used for shallowpenetration of the staple, mostly to fasten superficial tissues only.

The term “fastener” used in this invention encompasses tacks, staples,screws, clamps and other tissue holding devices.

(B) Anterior Cruciate Ligament Tear

Meniscal damage often accompanies a torn anterior cruciate ligament,ACL, which stabilizes the femoro-tibial joint. Due to the linearorientation of the collagen fibers and the enormous tensile strengthrequired of the ACL, it is often difficult to reattach the ligament bysuture. When tensile forces are applied, the suture cuts and tears thecollagen fibers along their linear orientation. Therefore, thetraditional ACL repair is to abandon the torn ACL altogether. To replacethe ACL, a strip of patellar ligament is harvested from the patient. Twobone holes are drilled, one through the tibia and another through thefemur. The strip of patellar ligament is threaded through the boneholes. Both ends of the patellar ligaments are then stapled to theanterior surfaces of femur and tibia through incisions of skin coveringeach bone. The traditional ACL repair is an invasive surgery. Tominimize the degree of invasiveness and eliminate opening the skin forligament stapling, bone fixation devices (U.S. Pat. No. 5,147,362 toGoble, 1992, U.S. Pat. No. 5,129,902 to Goble, et. al. 1992) aredesigned to grip the ligament replacement inside the drilled hole of thebone.

(C) Bulging or Herniated Disc

Low-back pain is one of the most prevalent and debilitating ailments ofmankind. For many people, no position can ease the pain or numbness, noteven bed rest. It is often the reason for decreased productivity due toloss of work hours, addiction to pain-killing drugs, emotional distress,prolonged hospital stays, loss of independent living, unplanned earlyretirements, and even financial ruin. Some may experience itoccasionally; others suffer from it for years. One common reason forthis chronic pain is the bulging or hemiation of an intervertebral disc,which can cause sciatica

The traditional surgical treatment for a bulging or herniated disc is aseries of tissue removing, filling and supporting procedures: (1)laminectomy, removal of the lamina from the vertebra which covers partof the herniated disc, (2) discectomy, removal of the disc, (3) boneharvesting usually from the patient's iliac crest, (4) bone cementfilling of the donor site, (5) donor bone packing into the vacant discspace, (6) adjacent vertebra supporting with rods, connectors, wire andscrews, and finally, (7) surgical site closing.

After a discectomy, numerous postoperative complications can occur. Themajor ones are lumbar scarring and vertebral instability. The scartissue extends and encroaches upon the laminectomy site andintervertebral foramen, then once again, pain returns, which leads tomore surgery. In fact, re-operation is very common. Unfortunately, thesuccess rate of re-operation is often less, in some cases, far less thanthe first. More operations lead to more scarring and more pain. Currentemphasis to the patients is to avoid surgical procedures, unless thepain and inconveniences are absolutely unbearable.

Even for the fortunate patients with long term success followingdiscectomies twenty years ago, their isokinetic test results clearlyindicate weaknesses compared to populations without discectomies.

There was and still is increasing interest in less invasive surgicaltechniques on the spine to reduce both trauma and cost. The majorobjectives of surgery on bulging or herniated lumbar discs are (1)decompression of the involved nerve root or roots, and (2) preservationof bony spine, joints and ligaments.

Chymopapain is an enzyme used to digest away the nucleus pulposus, thegel-like substance in the central portion of the disc, which thencreates space for the bulging part of the disc to pull back from theencroached nerve root. The needle for injecting the chymopapain isaccurately guided to the mid-portion of the disc by a stereotaxicdevice. The overall success rate is documented as high as 76%. However,some patients are allergic to the treatment and die from anaphylaxis.Some others suffer from serious neuralgic complications, includingparaplegia, paresis, cerebral hemorrhage and transverse myelitis (LumbarSpine Surgery, Arthur White, M.D., Richard Rothman, M.D., Charles Ray,M.D.)

Percutaneous nuclectomy is an alternative method for removing nucleuspulposus without the allergic reaction of chymopapain. Similar tochymopapain injection, a needle followed by a tube-like instrument isguided and confirmed by anteroposterior and lateral fluoroscopy. Thenucleus pulposus is then removed by mechanical means or by vacuum. As aresult, a void is created within the disc and the bulging decreases,like the air being released from a worn out tire, with the hope that thebulging portion of the disc will recede and no longer encroach upon theadjacent nerve root. This type of procedure is often referred to as adecompression procedure. Unfortunately, there is no guarantee that thedecompression will reduce enough bulging or herniation to alleviatepain.

Regarding immediate postoperative complications, percutaneous nuclectomyappears to be safer than either discectomy or chymopapain. There islittle epidural scarring, allergic reactions, or serious neurologiccomplications. However, the case history using this percutaneousprocedure has been relatively short, and the long-term outcome is notyet known.

The function of the nucleus pulposus, with its high water absorbingcomposition of mucoprotein and mucopolysaccharides, is to sustainprolonged compression during the day, and to resiliently re-inflate andre-establish disc height during the night. The pulposus is retained andsurrounded by layers of cartilaginous annulus. Together the pulposus andthe annulus behave as a resilient and cushioning water balloon. In theerect position, the weight of the body constantly compresses upon astack of these water balloons alternating between a series of vertebrae.During constant compression, the pulposus in each disc also behaves as awater reservoir, which is slowly and constantly being squeezed anddrained of its water content through the end plates connected to thevertebrae. As a result, the disc height decreases throughout the day.During bed rest, the weight of the body no longer compresses the disc.Due to the water absorbing nature of the nucleus pulposus, the flow ofwater is now reversed from the vascular vertebrae back into themucoprotein and polysaccharides. As a result, the disc height isreestablished, ready to provide support for another day (ClinicalBiomechanics of the Spine, 2nd ed., Augustus White, M.D., ManoharPanjabi, Ph.D.).

Aging, poor posture and trauma from heavy lifting contribute to anincrease in annular fibrotic elements. The disc dries out and greatlyloses height between vertebrae. Bone around the dried out disc grows arim and spurs, which protrude and invade the intervertebral foramina andinfringe upon nearby nerves. This continual, painful bone growth processcauses stenosis.

After the removal of the water absorbing and water retaining pulposus bythe percutaneous procedure, the remaining disc is no longer assembled asa water balloon; the annulus becomes more like a flat tire with minimalresiliency. In the erect position, compression forces are solely exertedupon the cartilaginous annulus alone. During bed rest, little if anywater is re-absorbed by the annulus. With the passage of time, it isconceivable that the annulus will flatten out and the disc height willpermanently decrease. As the vertebrae above and below the disc comecloser together with less and less disc space, the growth of bone spursand rim appear. The stenotic process has just begun. The pain returns.Unfortunately, unlike the previous irritation by the bulging disc, thistime the sensation of pain comes from nerve compression by solid bones.Surgical procedures can be very involved, and the potentialcomplications and scarring can be enormous.

In short, percutaneous nuclectomy may be a quick fix for decompressing abulging or herniated disc without allergic reaction. However, within anot so distant future, there may be a much more complicated and painfulailment waiting.

Recently, several devices (U.S. Pat. No. 5,800,550 to Sertich, 1998;U.S. Pat. No. 5,683,394 to Rinner, 1997; U.S. Pat. No. 5,423,817 to Lin,1995; U.S. Pat. No. 5,026,373 to Ray et. al., 1991) were designed tofortify the disc space between vertebrae. These types of devices arefrequently referred to as spinal cages. Before inserting the device intothe disc, the affected disc with portions of vertebral bone above andbelow the disc are cored out. Usually two holes are cored, one on eachside of the disc, to insert two spinal cages. Donor bone or bone-growthpromoting substances are packed into the porous cages. As the vertebraeheal from the coring, new bone grows into and permanently secures theporous cages. The purpose of using spinal cages is to replace the discand keep the vertebrae apart. However, these vertebrae are permanentlyfused to each other, without resilient cushion, rotation or flexibility.

An improved version of a metallic spinal fusion implant (U.S. Pat. No.5,782,832 to Larsen and Shikhman, 1998) tries to provide both rotationaland cushioning capability. This invention resembles a disc prosthesisfollowing a complete discectomy. Therefore, at least all thecomplications and postsurgical problems associated with a discectomyapply when this device is used.

(D) Tendon or Ligament Tear

In many accidents or sports related injuries, tendons or ligamentsrupture from bones. Some very strong bone anchors (U.S. Pat. No.5,851,219 to Goble et. al., 1998; and U.S. Pat. No. 5,478,353 to Yoon,1995) have been invented and used with sutures to reattach rupturedtissues. Attached to a suture, the anchor is inserted into a pre-drilledbone hole. The suture usually comes with a needle for sewing andattaching the torn tissue back to bone. The manipulation of suture andattachment of tissue requires not only skill and time from the surgeon,it also requires operative space in the body of the patient. To obtainthe space for suture manipulation, a sizable incision or multipleincisions are often required to complete a repair.

(E) Urinary or Fecal Incontinence

Urinary or fecal incontinence is far more common than expected. A recentfinding from a large telephone survey of over 2500 households withnearly 7000 individuals reveals that for anal incontinence alone, 2.2%of the general population has the problem. Incontinent problems, urinaryand fecal alike, can and usually do alter the lifestyles of thesuffering individuals, resulting in (1) social withdrawal, (2) decreasedexercise, (3) altered clothing choices, (4) minimized travel, (5)avoidance of sexual relationships and/or (6) spending over $2,000 peryear for disposable or washable pads, laundry, medications and skin careproducts (Urology Times, February 1996).

One of the major causes of fecal incontinence in women is vaginaldelivery of babies. In the United States, between 4% and 6% of women whohave vaginal deliveries suffer from fecal incontinence. Fecalincontinence often coexists with urinary incontinence and may signifypudenda nerve damage. Many of these patients were found to have a weakanal sphincter, as evidenced by low anal squeeze pressures. Disruptionof the anal sphincters has been attributed to episiotomies, perineallacerations and forceps extractions.

There are several other common causes of fecal incontinence. With age,the internal anal sphincter thickens with fibrotic tissue and loses theviscoelastic properties, which are required for closure. Also, traumacan tear and permanently scar the sphincter, resulting in a continualleakage problem.

Open surgery is often performed to tighten the sphincter muscle with asuture or to replace the sphincter with an artificial elastic band. Likeall other open surgeries, the incision is large; recovery is lengthy;and the medical cost is high. Furthermore, unlike most other surgicalsites, which can recover undisturbed, fecal excretion is unavoidable.Sphincter repairs often encounter infection, hemorrhage, hematoma and/orother complications.

For stress urinary incontinence, there are more successful surgicalprocedures and effective devices to treat women than the ones used totreat men. For example, collagen, a paste-like formulation, is used toinject and bulk up the sphincter wall. Alleviating incontinence afterone collagen treatment is rare for women, and it often requires five tosix treatments to achieve a satisfactory level for men. Even for theindividuals who endure the injections, collagen often tends to lose itsbulk within a few months. Similarly, fat injections have been tried andare reabsorbed by the patient within months. Teflon-based non-absorbablematerials were used, but the materials migrate away and lose their bulkand effectiveness (Urology Times, December 1997).

A disposable, inflatable urethral occlusive device has been designed forwomen (Urology Times, March 1995), and a penile clip for men (U.S. Pat.No. 4,942,886 to Timmons, 1990). These devices are very unnatural anduncomfortable.

For women, there are several common and effective surgical proceduresfor repairing intrinsic sphincter deficiencies. A vaginal sling providesan elastic support to the sphincter unit by compressing the vaginal wall(Urology Times, July 1994). However, this surgical procedure can alterthe patient's sexual function. Bladder neck closure is infrequentlyperformed and is irreversible. Potential complications of these surgicalprocedures include prolonged urinary retention, suprapubic pain,cellulitis, entrapment of genitofemoral or ilioinguinal nerve, vaginitisand/or suture infection (Glenn's Urologic Surgery, fifth edition, editorSam Graham Jr., M.D., 1998).

(F) Carpal Tunnel Syndrome

Carpal tunnel syndrome is a painful and debilitating ailment of the handand wrist widely believed to be caused by prolonged repetitive handactivities. Predisposing factors include congenital narrowing of thecarpal tunnel, trauma to carpal bones, acute infection, endocrineimbalance, contraceptive medication or rheumatoid disease. The weakness,numbness, pain and clumsiness of carpal tunnel syndrome are mainlyattributable to swelling or thickening of the tenosynovium andcompression of the median nerve under the flexor retinaculum. Prolongedcompression can lead to narrowing of the nerve with intraneuralfibrosis, resulting in irreversible loss of function.

The conservative treatment using splintage to restrict hand and wristactivity is helpful for about 70% of the patients. With the restrictedhand and wrist, many patients can no longer perform their jobs.Corticosteroid injections are often effectively used to reduce theinflammatory edema around the median nerve, but corticosteroids are nota long-term solution.

The most common surgical procedure for relieving compression of themedian nerve is carpal tunnel decompression, which enlarges the carpaltunnel by severing the entire width of the flexor retinaculum. After theprocedure, the hand is restricted for a month. Weakness and pain arefelt for some time. Even with the surgical procedure, about 10% of thepatients experience no improvement or even more pain (Carpal TunnelSyndrome, Bruce Conolly, FRCS, 1984).

Carpal tunnel decompression is often associated with one or moresurgical complications. Early postoperative complications includehematoma, edema and infection. Subsequent common complications areweakness of grip, stiffness of fingers, wrist and shoulder, adhesions offlexor tendons and/or pain from scar tissue entrapment of the cutaneousnerve (Hand Rehabilitation, 2nd Ed., Gaylord Clark, M.D, et. al.).

(G) Tumor and Blood Supply

Tumors, uncontrolled and rapidly growing tissues, demand extra nutrientsby tapping adjacent arteries to feed and multiply the cancer cells. Oneof the most effective treatments of tumors is surgical removal. Often,the tumor is too large or too close to delicate tissues, such as nerves.To reduce the size of the tumor prior to surgical removal, radiation andchemotherapy are commonly used. However, both of these supportingtechniques are invasive to the patients, who may face a long battle withcancer. As a less invasive approach, drugs are currently underinvestigation for reducing the new arterial growth feeding the tumor.These drugs are not likely to affect the existing arteries alreadyfeeding the tumor.

SUMMARY OF INVENTION

In keeping with the foregoing discussion, the present invention takesthe form of a resilient fastener, which can be guided, delivered anddeployed into tissue to provide a strong holding strength with sustainedgripping forces. The fastener may be deployed using a fastener deliverydevice according to the methods described herein or by other devices andmethods.

The fastener can reattach torn tissue, anchor a suture, fortify tissue,fasten protruded tissue, elastically close a sphincter, partially closea canal, permanently close a vessel or beneficially alter the shape oftissue.

Following the deployment of the first fastener, additional fasteners canalso be deployed through the same puncture site providing additionalstrength, especially if different holding directions and positions areutilized. The additional fasteners may be deployed without completelywithdrawing the delivery device from the puncture site.

The major components of the fastener delivery device are two tubes; onetube fits inside the bore of the other. For tissue penetration purposes,the outer tube can be sharpened at the distal opening and will bereferred to as a needle. The main function of the inner tube is to holdthe fasteners, and will be referred to as a cartridge. Both needle andcartridge have slits on the walls opened to their distal openings. Asthe needle and cartridge rotate against each other, the slits can lineup, overlapping each other. When the slits overlap, they are in-phase.When the slits do not overlap each other, they are out-of-phase. For thecartridge, the slit is preferred to be opened length-wise from thedistal opening all the way to or near the proximal opening.

The third component of the fastener delivery device is the fasteneritself. The width of the fastener is no wider than the slits in thecartridge and in the needle. At least a portion of the fastener is madewith a spring-like, flexible, resilient, elastic, super-elastic or shapememory material, and at least a portion of the fastener consists oftissue gripping elements. The fastener is made with curvature andgripping elements. Due to the spring-like or shape memory portion of thefastener, it can be elastically straightened either by mechanicalconstraint or temperature and is capable of resiliently curving back toor near the original shape when mechanical constraint is lifted or atransformation temperature is met. For simplicity, the resiliency of thefastener described in the text of this invention will concentrate on themechanical constraint. However, it is understood that temperature mayalso be used.

The elastic fastener is or fasteners are loaded into the cartridge inthe needle and resiliently straightened by at least the inner wall ofthe needle. In the out-of-phase mode, the most distal fastener near thedistal opening of the cartridge is resiliently straightened only by theinner wall of the needle. The position of this fastener is called thedeploy position, because the fastener is, in fact, ready for deployment.As the cartridge or needle rotates from the out-of phase to the in-phasemode, where the mechanical constraint is removed from the fastener inthe deploy position, the resiliently straightened fastener resumes itsoriginal curved shape, protruding from the slits and gripping thesurrounding tissue. Since the slits of both cartridge and needle areopen distally, the deployed fastener is free to slide away from thedelivery device when the fastener device is withdrawn from the tissue.

To prevent fastener migration with time, tissue ingrowth holes orgrooves can be channeled into the fastener.

By indenting a portion of the slit opening of the needle, one canselectively deploy a portion of the fastener while the remaining portionof the fastener remains within the device. For example, the distal halfof the slit is made slightly wider than the proximal half. When theneedle and the cartridge slits are set nearly in-phase, or referred tohereinafter as semi-in-phase, the distal half of the fastener deploysinto the surrounding tissue while the proximal half of the fastenerremains within the device. A partially deployed fastener is calledsemi-deployed. The semi-deployed fastener is particularly helpful inendoscopic surgery. Using the gripping element on the deployed distalhalf, a surgeon is now capable of pulling, tightening and manipulatingthe tissue to be fastened for a superior and gap-free repair beforefully deploying the entire fastener.

To prevent the semi-deployed fastener from slipping out during tissuemanipulation, tapered fastener holding elements may be carved into orincorporated onto the inner wall of the needle. The holding elementsprovide anchoring for the portion of the fastener remaining in theneedle. The tapering prevents jamming of the fastener during thetransition between out-of-phase to in-phase.

Depending on the surgical needs, sometimes the proximal half of thefastener can provide better assistance in tissue manipulation than thedistal half of the fastener. It is possible to open the slit in ways toallow the deployment of either the distal or the proximal portion of thefastener in the semi-in-phase mode. One side of the slit is indented atthe distal half while the other side of the slit is indented at theproximal half. Depending on the direction of cartridge rotation,relative to the needle, the semi-in-phase mode can bring out either thedistal or the proximal end of the fastener, with tapered fastenerholding elements supporting both semi-deployments.

The outer needle may have penetration markers to indicate the depth oftissue penetration. Furthermore, the needle has one or more orientationlines. The line may run longitudinally from the slit through the lengthof the needle to indicate the deploy direction of the fastener, thisorientation line is called the deploy line. In some surgicalmanipulations, the deploy line is mostly hidden by tissues. Anotherorientation line may also be marked longitudinally directly opposite thedeploy line, perhaps in a different color, pattern or shade; and iscalled the back line. The back line indicates where the back of thefastener will face.

The fourth component of the invention is a handle attached to theneedle. The needle handle is made strong enough to puncture soft boneand to rotate the needle. For surgical applications where both deployline and back line are invisible by direct view or endoscope, the needlehandle is fixed in a position relative to both lines to indicate thedirection of fastener deployment.

The fifth component of the invention is a handle for the cartridge. Thecartridge handle is attached to the cartridge and made sturdy enough toassist tissue puncturing, but the most important function is to rotatethe cartridge inside the needle. Similarly, the cartridge handle is alsofixed in a position relative to the slit of the cartridge to assist inestablishing the direction of fastener deployment.

Multiple fasteners can be loaded into the cartridge. After the firstfastener is deployed, a fastener advancing device pushes anotherfastener into the deploy position. For example, a simple plungerconnected to a mechanical lever can be used to advance fasteners oneafter another into the deploy position.

To prevent accidental puncturing of the surgeon or unintended tissue ofa patient by the sharp needle, a moveable sleeve may be extended tocover the needle. In addition to the protective purpose, the sleeve canalso serve numerous functions to assist surgeries. After the needle isinserted into tissue, the sleeve can be used to push and position thepunctured tissue into proper place for an optimal reattachment. Tofasten a bulging or herniated disc, the sleeve may be used to push andhold in the bulging annulus during the deployment of fasteners.

The fastener delivery device utilizes the rotating cartridge, relativeto the needle, to deploy fasteners into tissue through overlappingslits. Similar fasteners can be resiliently straightened in a needlewithout the cartridge, but with a plunger fitted inside the needlebehind the fastener. After insertion of the needle into tissue, theplunger is held stationary while the needle is slowly retracted orwithdrawn from tissue, thereby deploying the fastener out of the distalopening of the needle. In tissue, the fastener resumes the originalresilient curvature and tightly fastens onto the tissue. Multiplefasteners can also be loaded into the needle and deployed one at a timeinto different locations.

The fasteners can be made with alloy, pure metal, polymer, ceramic orcomposites. The fasteners can also be formed from modular parts, coatedwith lubricants, drugs, growth factors, antibiotics, hydrophiliccompounds, hydrophobic compounds, self-sealing materials, swellablecomponents, plasma coating or other substances. The curvature of thefasteners can be made symmetrical, asymmetrical or with multiplecurvatures. The fasteners or parts of the fasteners can be made withbiodegradable materials or with permanent materials. The fasteners orparts of the fasteners can be attached with or attached to a suture orother fastening devices.

SUMMARY OF METHODS AND ADDITIONAL EMBODIMENTS

In preparation for use, the fastener delivery device is set in theout-of-phase mode with a fastener in the deploy position. The tissueneeding to be fastened is chosen, prepared and arranged. The device isthen guided to the proper depth and orientation by the penetrationmarkers, orientation line(s), endoscope, X-ray, ultrasound, MRI and/orother technique.

(A) Meniscal Repair

Guided by an arthroscope and the penetration markers, the devicepunctures the meniscal body and traverses the tear. Through the indentedslit of the needle, the distal half of the fastener with grippingelement is deployed. The torn portion is gently pulled in andmanipulated back to the main body of the meniscus, then the fastener isfully deployed by setting the cartridge fully in-phase to close thetear. The device is now ready to be withdrawn, or another fastener maybe deployed through the same puncture site in a different direction toensure a tight closure.

To deploy another fastener, the cartridge is reset from the in-phaseback to the out-of-phase position. Another fastener is advanced in thecartridge chamber to the deploy position. The needle handle may then beused to rotate the device, for example, by 180° for the deployment ofanother fastener. If two fasteners in the puncture site are sufficientto hold the tear at the location, the device is ready to be withdrawnfrom the meniscus. To prevent accidental scraping of the delicatearticular cartilage in the knee joint, the sleeve may be slid over thesharp needle before resetting the device to the out-of-phase position inpreparation for deployment of an additional fastener or prior towithdrawal of the device.

For simplicity in the remaining method summary, operative procedures ofthe device, such as out-of-phase, in-phase, fastener advancement, sleevesliding, device rotation, puncture or withdrawal will not be mentionedin great detail, unless the operation is greatly varied from thatdescribed above.

(B) Ligament Repair

To fortify the longitudinally oriented collagen fibers in a tornanterior cruciate ligament, ACL, some specially designed fasteners aredeployed to grip and bundle the collagen fibers of the ACL together likea collar. Frequently, the ACL is stretched and irreversibly lengthenedprior to breaking. Therefore, the collar may not always be placed nearthe end of the tear. The placement of the collar is determined aftermanipulating and fitting the torn ACL in the patient's leg to ensureappropriate length after reattachment.

A ligament holding device may also be included to hold the ACLstationary and to guide insertion of the fastener delivery devicecontaining the collar fasteners.

For ACL tears close to the tibia or femur, a trocar is passed throughthe collar to the bone to establish an ACL reattachment position. Acannula is inserted as a sleeve over the trocar and contacts the bone.The trocar is then removed and replaced with a drill having drill stopsto prevent excessive penetration into the bone. After drilling, thedrill is removed and replaced with the fastener delivery device into thedrilled hole through the cannula. Unlike the collar fasteners mentionedearlier, the gripping elements for the bone attachment are designed toresist vertical or longitudinal pull out. The length of the fasteners issufficient to span the depth of the drilled hole to beyond the collar inthe torn ACL. Prior to deployment of the fasteners, the cannula islifted beyond the slit of the needle. The collagen fibers of the ACL arein contact with the delivery device, especially with the slit portion ofthe needle. The first fastener is then deployed. The gripping elementson one end of the fastener anchor onto the collar-fortified ACL fibersor may even latch onto the collar itself. The gripping elements on theother end of the fastener anchor into the hole in the bone. Due to thespring-like property built into the fastener body, the gripping elementsat both ends are constantly compressing the tissues, in this case theACL fibers and bone, making the fastening strength exceptionally strong.To ensure adequately strong reattachment, multiple fasteners, preferablydeployed in different directions, can be loaded into the same drilledhole without lifting the fastener delivery device.

Often, the ACL is torn at or near its mid-section. A similar techniqueusing the ligament holder and collar fasteners is used to install twosets of collars, one on each torn end of the ACL. The fastener deliverydevice is threaded through the collars. The fastener delivery device isloaded with fasteners similar to the ones used to attach the ACL tobone. With the indented slit on the needle, partial deployment of thefirst fastener is helpful to pull and manipulate the distal ACL fragmentinto place. Sliding the sleeve over the needle can also be used to pushtissue, in this case the proximal ACL fragment, to tightly rejoin thedistal ACL fragment. The fastener is then fully deployed, gripping bothfragments of ACL fibers fortified by two sets of collars.

(C) Tendon Repair

The fastener delivery device of the present invention can be usedthrough a small opening to reattach a tendon back to the bone withoutsewing, manipulating or tying sutures. Similar to reattaching the ACL tobone, a trocar is used to pierce and guide the tendon into the properposition, where a hole will be drilled in the bone. A cannula isinserted over the trocar, and then the trocar is replaced with a drillcreating a hole in the bone. The drill is then replaced by the fastenerdevice inserted through the tendon into the bottom of the bone hole. Thecannula is lifted so that the slit opening of the device is in contactwith tendon tissue. If necessary, the tendon can be pushed andpositioned by the sliding sleeve. The fasteners in the device shouldhave sufficient length to grip both the bone and the tendon tissue. Withtime, similar to the reattached ligament, the tendon can and most likelywill permanently reattach back onto the bone.

For soft bone, such as the humeral head in the shoulder, the needle ofthe device could possibly pierce a tendon to be reattached and punctureinto the humerus without using the trocar, cannula and drill. The sleeveof the device may be used to manipulate the tendon for a tight andpermanent repair.

(D) Bulging or Herniated Disc Fastening and Repair

To fasten bulging or herniated discs, the spring-like fastenersmentioned in the invention are made extra long with multiple grippingelements. For the best result, the needle of the fastener deliverydevice punctures the bulging portion and is guided into the disc byanteroposterior and lateral fluoroscopy or other technique. In caseswhere the bulging portion of the disc is well concealed by the lamina ofthe vertebra, a small amount of the bone can be removed to allowpenetration of the delivery device. When the appropriate depth isreached, the sliding sleeve is used to push and hold the bulging portionof the disc inward; the fastener is deployed to grip and compress thepreviously bulging tissue back in place. To make possible the push andhold technique using the sleeve during deployment of the fastener, thedistal opening of the sleeve also contains a slit, which may be orientedto overlap the slit of the needle. As the device is set in the in-phaseposition, the slits of the cartridge, needle and sleeve are aligned,allowing the fastener to deploy and hold the compressed tissue in place.Similar to previously mentioned surgical procedures, more than onefastener can be deployed through the puncture site, preferably towarddifferent directions, to enhance a permanent fastening. The spring-likefasteners with multiple gripping elements provide an exceptionallystrong holding strength with constant fastening forces holding back therepaired annulus, away from nerves.

The fastener directly, actively and elastically holds the bulging orherniated tissue back without removing the nucleus pulposus. Thereforethe bulging or herniated disc may be repaired without loss of nucleuspulposus.

Some surgeons may like to approach the disc repair anteriorly. Afterretracting the abdominal contents, the device can be guided, perhaps byfluoroscope or other means, through the disc to the bulging or herniatedportion. As the tip of the device reaches or nears the bulging surface,the distal half of the fastener is deployed. The bulging portion of thedisc is gripped and pulled inward, then the fastener is totally deployedto fasten the bulged disc.

To prevent possible leakage of the nucleus pulposus around the fastener,prior to device insertion into the disc, a sealing patch, made withelastic and biocompatible material with closure capability, is insertedon the needle against the distal opening of the sleeve. For bestresults, the sleeve is fixed proximally and stationary to provide aposition where the proximal tip of the soon to be deployed fastener willgrip the sealing patch. Using similar guiding, inserting and compressingtechniques, the sealing patch is tightly compressed, adhered or maybeeven embedded into the previously bulging or herniated annulus. As thefastener is deployed, it grips the patch to seal possible leakage ofnucleus pulposus. The sealing patch is a preventive measure and isoptional.

Other fastening devices can be used to fasten the bulging or herniatedannulus. A simple screw with tissue holding threads can be insertedthrough a pre-punctured hole, to compress and hold the bulging orherniated disc away from the encroached nerve. The screw can be madewith a locking device to prevent loosening and/or with threads having avariable pitch to compress bulging or herniated tissue. Depending on theseverity of the bulge or herniation, a simple staple or tack with tissueholding elements may be sufficient to fasten the weak annulus.

Suturing can also be used to fasten bulging or herniated discs. Forexample, the midsection of a small dumbbell-shaped rod is tied to asuture. The rod with suture is fitted inside a needle. Behind the rod, aplunger is inserted into the needle. The needle is guided through thebulging or herniated disc. With the plunger, the rod is pushed out ofthe distal opening of the needle, outside the annulus. The rod is nowcaught by the outer surface of the annulus and acts as an anchoringdevice for the suture. The needle is removed. A washer is threaded withthe suture, slipped down to the bulging disc, compressed and tied. Forsurgical convenience, the washer can be made in conjunction with asuture-locking device to eliminate suture tying. The suture may be madeof natural or synthetic fibers, such as gut, polymers and metals.

For fastening bulging or herniated discs, other fastening devices, suchas tacks, tissue anchors, staples or clamps, can also be used. Toprevent possible leakage of nucleus pulposus, a sealing patch can beused in conjunction with any of the fastening devices mentioned.

(E) Urinary or Fecal Incontinence Repair

For urinary and fecal incontinence, the spring-like fasteners of thepresent invention can be guided into the body and deployed to grip andelastically close the leakage of the sphincters. For insertion of thefastener delivery device, numerous existing guiding techniques, such ascystoscope, ultrasound, anteroposterior-lateral fluoroscopy, MRI orothers, can be used effectively and accurately to guide the insertionand deployment of the fasteners. Again, multiple fasteners can be usedto ensure proper closure of the sphincter.

To provide instant feedback to the surgeon, a pressure sensing catheterballoon, strain gauge, or tightening detecting instrument can beinserted into the leaking portion of the rectum and/or urethra As thefastener deploys and tightens the leaking portion, the instrument canprovide instant information to the surgeon regarding the placement andeffectiveness of the deployed fastener. For fluoroscopic imageenhancement, the catheter or instrument can be made or coated withradiopaque material to perfect the accuracy of the fastener deliverydevice insertion. For ultrasound image enhancement, echogenic enhancingmaterial can be used.

Especially among elderly patients, the elasticity of sphincters variesgreatly. Elasticity sensing balloons or instruments are particularlyhelpful in determining the elasticity of the sphincter tissues so thatsurgeon can select fasteners with appropriate closure strength andcurvatures for optimum repairs.

(F) Carpal Tunnel Syndrome Relief

Utilizing the elastic curvature of the fastener and the pliable natureof the flexor retinaculum, the fastener delivery device is inserted intothe flexor retinaculum, perpendicular to and over the median nerve. Asthe fastener is deployed toward the palm inside the retinaculum, thecurvature of the fastener forms the shape of an arch, lifting the flexortissue, which was compressing the median nerve. With several otherfasteners deployed side by side, a tunnel is created to relieve mediannerve compression without cutting the flexor retinaculum. The fastenerscan even be made with biodegradable materials, which degrade with timeafter relieving the pain.

(G) Double Indented Needle Slit for Versatile Tissue Manipulation andInter-locking Fasteners

Adding to the versatility of the fastener delivery device, the slit canbe double indented for semi-deploying either the proximal or distalportion of the fastener, depending on the direction of cartridgerotation. This feature is particularly helpful when alternating betweenfasteners to create interlocking tissue fastening. To enhance the doubleindented feature of the needle slit, the curvature of the fasteners canbe made asymmetrical. For example, the first fastener in the deployposition is made with a curvature near the proximal end of the fastener.The following fastener in the cartridge is made with a curvature nearthe distal end of the fastener. After semi-deploying the proximal halfof the first fastener, the tissue is tightened by pushing, then fullydeploying the first fastener. The device is slightly withdrawn and resetto out-of-phase. The following fastener is advanced into the deployposition. The distal portion of the second fastener is semi-deployedinto the tissue. For the second fastener, the tissue is tightened bypulling the device before full deployment. With tissue tightening bypushing and pulling, the fasteners interlock the tissue, through oneneedle puncture. In addition to pushing and pulling on the semi-deployedfasteners, twisting provides yet another dimension and benefit to thetissue manipulation and inter-locking fastening.

(H) Tumor Artery Closure

With an angiogram, the location of arteries supplying a tumor is mappedout. The fastener delivery device is inserted and guided to atumor-feeding artery. With the needle slit facing the artery, theproximal portion of the fastener is deployed under the artery. Thedevice may then be gently pushed to compress and restrict the artery.While pushing, the fastener is fully deployed to clamp and restrict theartery. If necessary, the device is slightly withdrawn, reset andanother fastener is advanced from the cartridge. The second fastener issemi-distally deployed over the artery. The device may then be gentlypulled to hook and further restrict the artery. While pulling, thesecond fastener is fully deployed to shut the blood flow. More fastenerscan be deployed to ensure a complete closure of the artery feeding thetumor.

(I) Other Features, Purposes and Summary

The needle of the device may be curved with a flexible cartridge toaccommodate rotation within the curved needle to reach under skin oraround organs and tissue into a target site.

Many other surgical procedures can utilize the fastener and the deliverydevice. Some examples follow. The fastener and delivery device canendoscopically attach dislocated organs. For weight loss purposes,fasteners can be used to slow stomach emptying by restricting thepyloric sphincter or pyloric canal. The fasteners can also be used toattach medical devices inside the body.

The fastener and the delivery device can serve in numerous endoscopicprocedures, which require connecting, reattaching, holding, fortifying,restricting, closing, compressing or decompressing tissues or otherdevices.

In brief summary, some of the possible benefits of the sustainedgripping fasteners and the delivery device follow: (1) grip tissuecontinuously, (2) minimize fastener migration, (3) minimally invasive,(4) deploy multiple fasteners within a puncture site, (5) access deepbody targets, (6) support and fortify fragile tissue, (7) reattachtissue without suture, (8) attach tissue to bone, (9) require minimalsurgical space, (10) attach to other fastening devices, (11) versatile,(12) provide permanent and/or degradable fastening, (13) simple to use,(14) manipulate tissue, (15) restrict or close orifices or vessels, (16)compress or decompress tissue, and (17) provide directional fastening.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts a fastener with an elastic or spring-like curvature.

FIG. 2 depicts a similar fastener as the one in FIG. 1 being resilientlystraightened by mechanical constraint (not shown) or by temperature.

FIG. 3 depicts an internal view of the fastener delivery device, wherefasteners are resiliently straightened in the cartridge inside theneedle. The needle slit and the cartridge slit are in the out-of-phaseposition.

FIG. 4 depicts an internal view of the fastener delivery device in thein-phase position, where both the needle slit and cartridge slit overlapor are aligned, allowing the deployment of the distal fastener.

FIG. 5 depicts an external view of the fastener delivery device in theout-of-phase position.

FIG. 6 depicts an external view of FIG. 5 in the in-phase positiondeploying a fastener.

FIG. 7 depicts the fastener delivery device inserted into torn tissue.

FIG. 8 depicts the deployment of the fastener into the tissue by settingthe device from the out-of-phase to the in-phase position.

FIG. 9 depicts the tissue after the device has been withdrawn, thedeployed fastener continues to elastically grip the torn tissue andcloses the tissue gap.

FIG. 10 depicts a distally semi-deployed fastener from an indentedneedle slit.

FIG. 11 depicts an inside view of the indented needle slit with taperedfastener holding elements.

FIG. 12 depicts the parts of a functional fastener delivery device.

FIG. 13 depicts a fully assembled fastener delivery device set in theout-of-phase position. The needle punctures the torn meniscus and theneedle slit is positioned within the plane of the meniscus to bridge thetorn tissue.

FIG. 14 shows the cartridge handle turned to the semi-in-phase positionto deploy the distal portion of a fastener, as indicated in FIG. 10, togrip the torn tissue.

FIG. 15 shows the torn tissue gently pulled in to tighten the torn gapwith the gripping of the distally semi-deployed fastener.

FIG. 16 shows the cartridge handle turned all the way to the in-phasemode to fully deploy the fastener holding the torn tissue in place.

FIG. 17 shows the device reset to the out-of-phase mode by turning thecartridge handle backward.

FIG. 18 shows the device with a fastener-advancing handle turned toplace another fastener in the cartridge into the deploy position.

FIG. 19 shows the delivery device turned to vary the direction of thenext fastener deployment with the needle remaining in the puncture site.

FIG. 20 shows the cartridge handle turned to deploy the next fastener tofurther secure the torn tissue.

FIG. 21 shows the device withdrawn from the puncture site and the sleeveextended to cover the sharp needle to prevent scraping of articularcartilage. The fasteners remain elastically fastening the torn tissue.

FIG. 22 depicts a ligament-holding device.

FIG. 23 depicts a torn anterior cruciate ligament, ACL, held by theligament holder. The fastener delivery device is inserted through theguiding track near the torn tissue of the ACL.

FIG. 24 depicts the deployed fasteners holding the ligament fibers likea collar above the torn tissue of the ACL.

FIG. 25 depicts a set of tissue manipulating and bone drilling tools: atrocar, a drill and a cannula.

FIG. 26 depicts the piercing of the trocar and the cannula through theACL onto the surface of the bone.

FIG. 27 shows the trocar replaced with a drill while the cannula is heldstationary on the bone.

FIG. 28 shows the cannula held stationary while the drill is replacedwith the fastener delivery device inserted into the bone hole.

FIG. 29 shows the cannula withdrawn from the ACL to allow the ACL fibersto contact the needle, especially the needle slit.

FIG. 30 depicts the anchoring of the ACL fortified by three fastenersextending from the cone-shaped hole in the bone to beyond the collarfasteners around the ACL.

FIG. 31 shows an ACL rupture more distant from bone. Two sets of collarfasteners are installed near the torn ends of the ACL. Three fastenersare deployed to reattach the collar fasteners fortifying the ACLfragments.

FIG. 32 depicts a tendon torn from the humerus. A fastener deliverydevice is inserted into the tendon and pierces the humerus.

FIG. 33 shows the tendon being positioned by the sleeve, as the tendonis reattached to the humerus.

FIG. 34 depicts a long fastener with spring-like or shape memoryelements and multiple gripping elements.

FIG. 35 depicts a nerve retractor lifting an impinged nerve away from abulging or herniated disc. A fastener delivery device is inserted with asealing patch into the bulging or herniated portion of the disc.

FIG. 36 depicts the compression of the bulging disc by the sleeve. Thesealing patch is also pressed against the bulging disc.

FIG. 37 shows the cartridge handle turned to deploy the fastener intothe disc while the sleeve and sealing patch compress the bulge.

FIG. 38 shows the device withdrawal with the fastener remaining withinthe disc, gripping and fastening the previously bulging annulus.

FIG. 39 depicts a sealing patch gripped by the proximal portion of thefastener outside the repaired annulus (not shown).

FIG. 40 depicts a disc fastening screw with a washer used to fasten abulging or herniated disc.

FIG. 41 depicts the fastening of the previously bulging or herniateddisc by the disc fastening screw.

FIG. 42 depicts another bulging or herniated disc fastening device usinga suture tied to a dumbbell shaped rod. A plunger is used to deploy therod and a washer is used for tying with the suture to compress thebulging disc.

FIG. 43 depicts the assembly of the rod, suture and plunger inside aspinal needle.

FIG. 44 depicts a puncture using the spinal needle containing theassembly of the rod, suture and plunger, as indicated in FIG. 43,through the bulging or herniated disc.

FIG. 45 shows the rod tied to the suture and deployed out of the distalopening of the spinal needle and out of the disc by the pushing of theplunger.

FIG. 46 shows the spinal needle withdrawn. The rod is anchored outsidethe disc holding the suture. The washer is then threaded through withthe ends of the suture.

FIG. 47 shows the previously bulging disc compressed by the washer andfastened by a suture knot.

FIG. 48 depicts a staple with annulus-holding barbs configured tocompress and fasten a bulging disc.

FIG. 49 depicts another type of staple with closure or shape memory legsto hold and fasten a bulging disc.

FIG. 50 depicts an insertion of the fastener delivery device to deployan elastic fastener into a leaking anal sphincter.

FIG. 51 depicts a deployed fastener, indicated by the dotted curvature,around the anal sphincter. The device is reinserted into another portionof the sphincter to deliver another fastener.

FIG. 52 depicts an elastic closure of the anal sphincter, in this casewith two spring-like fasteners.

FIG. 53A depicts a leaking sphincter due to incomplete closure.

FIG. 53B depicts the partial closure of the sphincter by a spring-likefastener.

FIG. 53C depicts the elastic closure of the sphincter by two spring-likefasteners.

FIG. 54 depicts possible entries for the fastener delivery devices fortreating urinary and fecal incontinence. Tightening detectinginstruments provide instant feedback to the surgeon after each fasteneris deployed.

FIG. 55 depicts a hand with carpal tunnel syndrome and insertion of afastener delivery device into the flexor retinaculum (not shown) underthe skin.

FIG. 56 depicts several deployed fasteners lifting the flexorretinaculum, creating a tunnel to accommodate the irritated median nerve(not shown) beneath it.

FIGS. 57A & B depict two fasteners with asymmetrical curvatures toenhance the effectiveness of inter-locking fasteners.

FIG. 58 depicts a needle of the fastener delivery device with a doubleindented slit to allow semi-deployment of either the distal or proximalportion of a fastener (not shown). Tapered fastener holding elements areindicated to anchor either semi-deployment.

FIG. 59 depicts a proximally semi-deployed fastener pushing, compressingand restricting an artery feeding a tumor.

FIG. 60 shows the fastener of FIG. 59 fully deployed. Another fasteneris distally semi-deployed, pulling and further restricting the bloodflow of the artery.

FIG. 61 depicts both fully deployed, inter-locking fasteners restrictingblood flow to the tumor.

FIG. 62 depicts a fastener with tissue ingrowth holes to minimizefastener migration.

FIG. 63 depicts another fastener with tissue ingrowth grooves designedto minimize fastener migration.

FIG. 64 depicts a fastener attached to a suture.

FIG. 65 depicts a simple fastener delivery device. A curved fastener isresiliently and elastically straightened in a needle followed by aplunger for deployment

FIG. 66 depicts modular gripping elements with stems fitting into thegripping element holes.

FIG. 67 depicts the assembled fastener with two modular grippingelements.

FIG. 68 depicts the sloped indentation of the needle slit with a deployline indicating the direction of fastener deployment.

FIG. 69 depicts the slanted indentation of the needle slit for selectinginitial protrusion of fastener deployment.

FIG. 70 depicts modular arms with connecting studs and hooks intoconnecting holes in a spring-like or shape memory element.

FIG. 71 depicts an assembled fastener with modular parts.

FIG. 72 depicts the back line of the needle.

FIG. 73 depicts a curved needle with cartridge and fastener inout-of-phase mode with the needle slit.

DETAILED DESCRIPTION OF THE EMBODIMENTS

In the present invention, a fastener can be guided, delivered anddeployed into tissue to provide a strong holding strength with sustainedgripping forces. The fastener can reattach torn tissue, anchor a suture,fortify a tissue, fasten protruded tissue, elastically close asphincter, partially close a canal, permanently close a vessel orbeneficially alter the shape of a tissue.

FIG. 1 depicts a fastener 13 formed of an elongated body beingelastically predisposed toward a curvature. When the fastener 13 assumesthe curvature, it it in the closed position. The ends of the fastener 13are blunt, rounded, flat, etc., thereby decreasing the likelihood of thefastener 13 puncturing the surrounding tissue. A plurality of grippingelements 14 are formed on one side of the fastener 13, near each end.Further gripping elements 14 may be located on other sides to decreasethe likelihood of migration of the fastener 13. All or a portion of thefastener 13 contains or is made of a spring-like or shape memory element15, thereby predisposing the fastener 13 towards the curvedconfiguration. If the shape memory element 15 is made with temperaturesensitive material such as nickel titanium, transformation temperatureis also very important.

FIG. 2 depicts a similar fastener 13 as the one in FIG. 1 beingresiliently straightened by mechanical constraint, not shown, or bytemperature acting on the shape memory element 15 of the fastener 13.The fastener 13 indicated is in an extended or open position.

The fastener 13 has a preferred range of lengths between 1.0 mm and 200mm, more preferably between 3.0 mm and 70 mm. The fastener 13 has apreferred width of 0.1 mm to 30 mm, more preferably between 0.5 mm and7.0 mm. Although not required, the fastener 13 is preferably configuredsuch that the resilient member does not exceed the elastic limit of thematerial chosen. For example, a stainless steel resilient member'sstrain should not exceed approximately 2%. A nickel titanium resilientmember's strain should not exceed 7-14%. The maximum strain variesdepending on the alloy, heat treatment and coldworking. If a polymer isused the percent of strain varies significantly depending on theparticular polymer chosen.

For the gripping elements 14 of the fasteners 13, the shape, direction,depth, pitch, angle, pattern, density, size and material can vary andcertainly are important for effective tissue fastening. The grippingelements 14 may be grooves, as shown, or other shapes such as chevrons,bumps, etc. Some cases require strong gripping power, while other casesrequire a weak grip. The characteristics of the gripping elements may beadjusted to maintain the desired grip. The structure, size, shape,length, elasticity of the material and curvature of the spring-like orshape memory element 15 are also important factors in determining theintensity of the grips of the fastener 13.

The gripping elements 14 and the spring-like or shape memory element 15of the fastener 13 can be made with one material or with multiplematerials. The materials used in making the fastener 13 can bedegradable, permanent or a combination of both. Due to the strength,superelastic and shape memory properties, nickel titanium is thepreferred material for making at least a portion of the fasteners 13.For biodegradable properties, polylactic resin, polyglycolic resin,biomaterial or other polymers can be used. Other metals, alloys,polymers, ceramics or composites can also be used.

The fasteners 13 can be coated or blended with lubricants, tissuecompatible components, antibiotics, growth factors, tissue sealingmaterials, hydrophilic or hydrophobic materials, drugs, drug releasingsubstances, swellable components, coatings, plasma coatings and/orothers.

The fasteners 13 can also be formed in one piece or from modular parts,discussed with FIGS. 66, 67, 70 and 71. The parts can be coated with orcontain lubricants, drugs, growth factors, antibiotics, hydrophiliccompounds, hydrophobic compounds, self-sealing materials, swellablecomponents, plasma coating or other substances.

The fastener 13 or parts of the fastener 13 can be made withbiodegradable materials, such as polylactic resin, polyglycolic resin orother polymer. Biomaterials, such as collagen, elastin or others, canalso be used as a biodegradable component in the fastener 13.

In addition to alloys or metals, numerous long lasting polymers can beused to make the fastener 13 or part of the fasteners 13. Polypropylene,polyethylene, polytetrafluoroethylene (PTFE) and many other polymers maymeet the requirements.

As will be discussed in further detail later, the curvature of thefasteners 13 can be made symmetrical, asymmetrical or with multiplecurvatures. The fasteners 13 or parts of the fasteners 13 can beattached with or attached to a suture 21 or other fastening devices.

FIG. 3 depicts an internal view of the fastener delivery device 73. FIG.4 depicts an internal view of the fastener delivery device 73 in thein-phase position. FIG. 5 depicts an external view in the out-of-phaseposition. FIG. 6 depicts an external view in the in-phase position.

The major components of the fastener delivery device 73 are two tubes 1,7; one tube fits inside the bore of the other. For tissue penetrationpurposes, the outer tube can be sharpened at the distal opening 16 andwill be referred to as a needle 1. The main function of the inner tubeis to hold the fasteners 13, and will be referred to as a cartridge 7.Both needle 1 and cartridge 7 have slits 2, 8 on the walls opened totheir distal openings 16, 17. As the needle and cartridge 7 rotateagainst each other, the slits 2, 8 can line up, overlapping each other.When the slits 2, 8 overlap, they are in-phase. When the slits 2, 8 donot overlap each other, they are out-of-phase. For the cartridge 7, theslit 8 is preferred to be opened length-wise from the distal opening 17all the way to or near the proximal opening.

The third component of the fastener delivery device 73 is the fastener13 itself. The width of the fastener 13 is no wider than the slits 2, 8in the needle 1 and in the cartridge 7. At least a portion of thefastener 13 is made with a spring-like, flexible, resilient, elastic,superelastic or shape memory material 15, and at least a portion of thefastener 13 consists of tissue gripping elements 14. The fastener 13 ismade with curvature and gripping elements 14. Due to the spring-like orshape memory 15 portion of the fastener 13, it can be elasticallystraightened to the extended or open position either by mechanicalconstraint or temperature and is capable of resiliently returning to ornear the original curved configuration or closed position whenmechanical constraint is lifted or temperature is met. For simplicity,the resiliency of the fastener 13 described in the text of thisinvention will concentrate on the mechanical constraint. However, it isunderstood that temperature may also be used. The elastic fastener 13 isor fasteners 13 are loaded into the cartridge 7 in the needle 1 andresiliently straightened by at least the inner wall of the needle 1. Inthe out-of-phase mode, the most distal fastener 13 near the distalopening 17 of the cartridge 7 is resiliently straightened only by theinner wall of the needle 1. The position of this fastener 13 is calledthe deploy position, because the fastener 13 is in fact ready fordeployment. As the cartridge 7 or needle 1 rotates from out-of-phase tothe in-phase mode, where the mechanical constraint is removed from thefastener 13 in the deploy position, the resiliently straightenedfastener 13 resumes its original curved shape, protruding from the slits2, 8 and gripping the surrounding tissue. Since the slits 2, 8 of bothneedle 1 and cartridge 7 are open distally, the deployed fastener 13 isfree to slide away from the delivery device 73 when the fastenerdelivery device 73 is withdrawn from the tissue.

The outer needle 1 has penetration markers 3 to indicate the depth oftissue penetration. Furthermore, the needle 1 has one or moreorientation lines, seen in FIGS. 58 and 72. The orientation line may runlongitudinally from the slit 2 through the length of the needle 1 toindicate the deploy direction of the fastener 13; this longitudinal lineis called the deploy line 65. In some surgical manipulations, the deployline 65 is mostly hidden by tissues. Another longitudinal line, the backline 66, perhaps in a different color, pattern or shade is also markedlongitudinally directly opposite the deploy line 65. The back line 66indicates where the back of the fastener 13 will face.

FIG. 3 shows the fasteners 13 resiliently straightened by mechanicalrestraint in the cartridge 7 inside the needle 1. The needle slit 2 andthe cartridge slit 8 are in the out-of-phase mode with a fastener 13 inthe deploy position and another fastener 13 below it. Under theconstrained condition, both fasteners 13 are in open position.

FIG. 4 depicts an internal view of the fastener delivery device 73,where both the needle slit 2 and cartridge slit 8 are aligned oroverlapped. Both slits 2 and 8 are open to distal openings 16, 17 of theneedle 1 and cartridge 7. As the slits 2, 8 align or overlap each other,the mechanical restraint is relieved for the distal fastener 13. Thefastener 13 resumes the curved shape by exhibiting a closed or clampedposition and is elastically deployed from the slit 2 of the needle 1. Inthe clamped position, the gripping elements 14 are on the concave sideof the closed fastener 13. But the proximal fastener 13 remaining in thefastener delivery device 73 is still resiliently restricted beneath theslit 2 of the needle 1.

FIG. 5 depicts an external view of the fastener delivery device 73 inthe out-of-phase mode. The top portion of a fastener 13 in the deployposition is visible near the distal opening 17 of the cartridge 7.Penetration markers 3 are indicated on the needle 1.

FIG. 6 depicts an external view of FIG. 5 in the in-phase mode deployinga fastener 13. The fastener 13 resumes the resilient curvature andprotrudes out the slit 2 of the needle 1.

In preparation for use, the fastener delivery device 73 is set inout-of-phase mode with a fastener 13 in the deploy position. The tissueneeding to be fastened is chosen, prepared and arranged. The device 73is then guided to the proper depth and orientation by the penetrationmarkers 3, deploy line 65, back line 66, endoscope, X-ray, ultrasound,MRI and/or other technique.

FIG. 7 depicts the fastener delivery device 73 punctured 32 into a torntissue 22. Guided by the penetration markers 3, endoscope or otherviewing technique, the slit 2 of the needle 1 is positioned to bridgethe tear. The direction of fastener deployment is easily controlled bysimply turning the needle 1 of the device 73.

FIG. 8 depicts the deployment of the fastener 13 into tissue by settingthe device 73 from out-of-phase to the in-phase mode. With grippingelements 14, the torn tissue 22 is being gripped; and the resumedcurvature of the fastener 13 closes the torn tissue 22 gap. When thedevice 73 is withdrawn, the deployed tissue gripping fastener 13 canslide out from the device 73 along both the slit 2 of needle 1 and theslit 8 of cartridge 7 shown in FIG. 4 since both slits 2, 8 are open tothe distal openings 16, 17 of needle 1 and of cartridge 7, also shown inFIG. 4.

FIG. 9 depicts the tissue after the device 73 has been withdrawn, thedeployed fastener 13 continues to elastically grip torn tissue 22 andcloses the tissue gap. The depicted curvature of the fastener 13 isbetween the resiliently straightened curvature in FIG. 2 and the fullcurvature depicted in FIG. 1 to indicate that torn tissue 22 is undersustained closure forces exerted by the fastener 13.

Following the deployment of the first fastener 13, additional fasteners13 can also be deployed through the same puncture site 32 providingadditional strength, especially if different holding directions andpositions are utilized. The additional fasteners 13 may be deployedwithout completely withdrawing the delivery device 73 from the puncturesite 32.

FIG. 10 depicts an example of an indented needle slit 2, where thedistal portion 74 of the needle slit 2 is wider than the proximalportion 75 of the needle slit 2. By indenting the slit 2 of the needle1, one can selectively deploy a portion of the fastener 13 while theremaining portion of the fastener 13 remains straightened within theneedle 1 of the device 73. When the needle slit 2 and the cartridge slit8 are set nearly in-phase, or called semi-in-phase, the distal half 76of the fastener 13 deploys into the surrounding tissue while theproximal half 77 of the fastener 13 remains within the device 73. Thehalf-deployed fastener 13 is particularly helpful in endoscopic surgery.Using the gripping elements 14 on the deployed distal half 76, a surgeonis now capable of pulling, tightening and manipulating the tissue to befastened for a superior and gap-free repair before fully deploying theentire fastener 13.

To prevent the half-deployed fastener 13 from slipping out during tissuemanipulation, fastener holding elements 60 may be carved as grooves intoor incorporated onto the inner wall of the needle 1, as shown in FIG. 11which depicts the inside view of the indented needle slit 2 with thefastener holding elements 60. The holding elements 60 may be taperedfrom very shallow ridges to taller ridges as they near the needle slit2. The fastener holding elements 60 in this example are designed to holdthe proximal portion 77 of the semi-deployed fastener 13 during pullingand tissue manipulation by surgeons. The fastener holding elements 60are tapered to minimize fastener 13 jamming during rotation fromout-of-phase to the semi-in-phase mode.

In an alternate embodiment, the entire fastener 13 may be deployedthrough the distal opening 16 of the needle 1 by removing the needlewhile holding a plunger within the needle 1 stationary. This embodimentmay still be used to manipulate the tissue after the distal end of thefastener 13 has been deployed, but before the proximal end of thefastener 13 is deployed. The proximal portion of the fastener 13 couldbe deployed by removal of the needle allowing the entire fastener 13 toexit through the distal opening 16, or the proximal portion of thefastener 13 could deploy through the slit 2 of the needle 1. In thisembodiment, the slit 2 could be shortened or omitted since none or onlya small portion of the fastener 13 need exit the side of the needle 1.

Other embodiments may have the edge of the slit 2 in the needle angledor tapered to gradually bring the fastener 13 towards its deployedconfiguration prior to full deployment or the edge may have a straightedge, i.e. cut generally perpendicular to the perimeter of the needle 1.

FIG. 12 depicts an example of a functional fastener delivery device 73with individual parts. The device assembly follows. The sleeve 18 fitsover the needle 1. To keep both sleeve slit 19 and needle slit 2 alignedor overlapping, a sleeve handle 20 is inserted into a sleeve-slidingtrack 59 to prevent the sleeve 18 from rotating. The proximal opening ofthe needle 1 is in the needle body 61. The cartridge 7 extending fromthe cartridge body 62 is inserted through the proximal opening of theneedle 1. The cartridge body 62 is housed in the needle body 61. Thecartridge 7 and the cartridge body 62 are operated by a cartridge handle9, which extends through the side of needle body 61. The cartridge unitsare retained by a cartridge cap 58. For advancing fasteners 13, notshown, in the cartridge, a fastener-advancing plunger 10 is insertedthrough a hole of the cartridge cap 58 and the cartridge body 62 intothe proximal opening of the cartridge 7. The fastener-advancing device11 works in conjunction with the cartridge body 62 to advance fasteners.At the proximal end, a fastener-advancing handle 12 is used to drive theadvancing units, pushing the fastener toward the deploy position. In theout-of-phase position, fasteners 13, not shown, can then be loaded, oneby one, through the distal openings 16, 17 of the needle 1 and thecartridge 7.

The needle handle 6 is made strong enough to puncture soft bone and torotate the needle 1. For surgical applications where both deploy line 65and back line 66 are invisible by direct view or endoscope, the needlehandle 6 is fixed in a position relative to both lines 65, 66 toindicate the direction of fastener 13 deployment.

The cartridge handle 9 is made sturdy enough to assist tissuepuncturing, but the most important function is to rotate the cartridge 7inside the needle 1. Similarly, the cartridge handle 9 is also fixed ina position relative to the slit 8 of the cartridge 7 to assist inestablishing the direction of fastener 13 deployment.

Multiple fasteners 13 can be loaded into the cartridge 7. After thefirst fastener 13 is deployed, a fastener advancing device 11 pushesanother fastener 13 into the deploy position.

For example, a simple plunger 10 connected to a mechanical lever actingas a handle 12 can be used to advance fasteners 13 one after anotherinto the deploy position.

To prevent accidental puncturing of the surgeon or unintended tissue ofa patient by the sharp needle 1, a moveable sleeve 18 may be extended tocover the needle 1. In addition to the protective purpose, the sleeve 18can also serve numerous functions to assist surgeries. After the needle1 is inserted into tissue, the sleeve 18 can be used to push andposition the punctured tissue into proper place for an optimalreattachment. To fasten a bulging or herniated disc 41, the sleeve 18can be used to push and hold in the bulging annulus during thedeployment of fasteners 13. Skilled surgeons may also prefer to addrotational movements using tissue manipulating elements at the distalend of the sleeve 18.

(A) Meniscal Repair

Within the body, there are a number of menisci, typically near circularor crescent-shaped fibrocartilage or dense fibrious tissue structureswhich appear between bones. For the example given herein, meniscus willrefer to a meniscus within the knee, however, the technique may be usedon other menisci and other similar structures.

For meniscal repair, the device 73 is effective for both outside-in andinside-out approaches. The outside-in approach is to enter from thethick peripheral rim of the meniscus 26 toward the thin tapering portionof the meniscus 26. The inside-out approach is to enter from the thinportion toward the thick rim. The inside-out approach is more frequentlyused by surgeons using suture or meniscal tacks because it is lesslikely to rupture vessels and nerves. The fasteners 13 and deliverydevice 73 in the invention can accommodate both approaches. However, thedrawings and method summary are depicted using the inside-out approachonly.

FIG. 13 depicts a very common meniscal tear 22 near nerves 25, arteries23 and veins 24 in the knee of a patient. If the repair is done withsuture, skin and muscle would be opened and the nerves 25, arteries 23and veins 24 would all be retracted to prevent possible damage duringsuture passage and manipulation. For fastener 13 repair, nothing passesthrough the delicate area; therefore, opening the skin and muscle of thepatient to retract the nerve 25 and blood vessels is not necessary. Afully assembled fastener delivery device 73 is set in the out-of-phasemode. Guided by an arthroscope, not shown, and penetration markers 3,the needle 1 punctures the torn meniscus 26 and the needle slit 2 ispositioned within the plane of the meniscus to bridge the torn tissue22. Through the indented slit 2 of the needle 1, the distal half 76 ofthe fastener 13 with gripping element(s) 14 is deployed as indicated inFIG. 14.

FIG. 15 shows the torn tissue 22 gently pulled in to tighten the torngap with the gripping elements 14 of the distally semi-deployed fastener13; in this case, it also grips the capsule 27.

FIG. 16 depicts the cartridge handle 9 turned all the way to thein-phase mode to fully deploy the fastener 13 holding the torn tissue 22in place. The device is ready to be withdrawn, allowing the deployedfastener 13 to slide out of the distal openings 16, 17 of the needle 1and the cartridge 7 indicated in FIG. 4.

For the highest holding strength, the tear 22 should be at or near themid-portion of the fastener 13. The direction of fastener 13 deploymentis preferably within the plane of the meniscus 26. The device 73 is nowready to be withdrawn, or another fastener 13 may be deployed throughthe same puncture site in a different direction to ensure a tightclosure.

To deploy another fastener 13 into the puncture site, the cartridge 7 isreset from in-phase back to out-of-phase mode as indicated in FIG. 17.However, it is possible that a portion of the deployed fastener 13 mayremain in the cartridge 7 and restrict the cartridge 7 from rotatingback to the out-of-phase mode. To free the cartridge 7 from the deployedfastener 13, the device may have to be slightly withdrawn from thepuncture site 32 to depart or be free from the deployed fastener 13prior to rotating.

FIG. 18 shows the device 73 with the fastener-advancing handle 12 turnedto position another fastener 13 in the cartridge 7 into the deployposition. The fastener-advancing device 11, not shown in this figure, ispreferred to provide advancement of one fastener length for eachsemi-rotation of the fastener-advancing handle 12. Other mechanicaldesigns for advancing fasteners 13 are possible.

The needle handle 6 may then be used to rotate the device 73, forexample, by 180° as shown in FIG. 19. Presumably the first fastener 13has already closed the tear 22, so tissue manipulation by thehalf-deployed fastener 13 technique is probably unnecessary. The secondfastener 13 may, therefore, be fully deployed as shown in FIG. 20 tofurther secure the torn tissue 22. In this case, two fasteners 13 aredeployed within the plane of the meniscus and with the deploymentdirections 180° from each other, within the puncture site.

FIG. 21 shows the device withdrawn from the puncture site 32. Thefastener 13 slides through the slits 2, 8 and distal openings 16, 17 ofboth needle 1 and cartridge 7, as indicated in FIG. 4, and elasticallyfastens the torn tissue 22. In this case, there are a total of twodeployed fasteners 13 holding the torn portion 22 of the meniscus 26.The sleeve 18 is then extended to cover the distal end of the needle 1to prevent scraping of articular cartilage after the device 73 iswithdrawn and possibly reset within the knee joint. Another fastener 13can be advanced for another fastening if desired.

Due to the enormous pressures exerted at the femoro-tibial joint,meniscal tacks in the market today can creep and leave unhealing gapsalong the meniscal tear. The spring-like fasteners 13 in this invention,on the other hand, provide not only strong holding strength, they alsoprovide spring-like closure forces rejoining the torn tissue 22, therebyallowing the meniscus 26 to serve its function and to heal.

Although meniscal suture repair is believed to be reliable, it requiresmultiple and/or large incisions or entry points; and retractors areoften required to pull aside blood vessels, nerves and even expand jointspace for passage and manipulation of the suture. Each of theseretractions involves risks, post-surgical complications, prolongedhealing time and increased medical costs. On the other hand, thedelivery device 73 for the spring-like fasteners 13 in the presentinvention consists of a needle 1 and components in the needle 1, whichonly require a small entry for fastener 13 delivery.

For simplicity in the remaining method descriptions, operativeprocedures of the device 73, such as out-of-phase, in-phase, fastener 13advancement, sleeve 18 sliding, device 73 rotation, puncture orwithdrawal will not be mentioned in great detail, unless the operationis greatly varied from that described above.

(B) Ligament Repair

During injury, meniscal 26 tears often accompany torn anterior cruciateligaments 28 (ACL). As mentioned, the linear orientation of collagenfibers in the ACL 28 and the tensile strength requirement make itdifficult to securely reattach the tear by suture, staple or any otherexisting means. Frequently, another ligament in the body is harvested oran artificial prosthetic device is used with extensive surgicalincisions, drillings and attachments to replace the ACL 28.

To fortify the longitudinally oriented collagen fibers in a torn ACL 28,some specially designed fasteners 13 are deployed to grip and bundle thecollagen fibers of the ACL 28 together like a collar. Frequently, theACL 28 is stretched and irreversibly lengthened prior to breaking.Therefore the collar may not always be placed near the end of the tear.The placement of the collar is determined after manipulating and fittingthe torn ACL 28 in the patient's leg to ensure appropriate length afterreattachment.

FIG. 22 shows a ligament holding device 81 with a handle 31, deviceguiding tracks 30 and a ligament holder 29. The ligament holding deviceis designed to hold the ACL 28 stationary and to guide insertion of thefastener delivery device 73 containing the collar fasteners 13 duringendoscopic repair of a ligament 28.

FIG. 23 shows a torn ACL 28 held by the ligament holder 29. Guided by anarthroscope, not shown, through the device guiding track 30, thefastener delivery device 73 is inserted near the torn tissue 22 of theACL 28. Specifically designed fasteners 13 for gripping and holdingligament fibers are deployed in the ACL 28, in this example, one on eachside positioned by the guiding tracks 30.

FIG. 24 depicts the deployed fasteners 13 holding the ligament fiberslike a collar or ring above the torn tissue 22 of the ACL 28. Thecurvature and closure strength of the collar fasteners 13 are designedto hold, bundle and fortify the collagen fibers of the ligament 28. Thegripping elements 14 of the collar fasteners 13 are designed anddirected to resist, in this example, the downward pulling forces. Thefastener delivery device 73 puncture sites 32 are shown.

FIG. 25 depicts a set of tissue manipulating and bone drilling tools forreattaching a torn ligament or tendon. For ACL tears close to the tibiaor femur, a trocar 33 having a sharp distal tip is passed through thecollar to the surface of the bone 38 to establish an ACL 28 reattachmentposition. A cannula 34 with a handle and a sharp distal tip is insertedover the trocar 33 and contacts the bone 38, as shown in FIG. 26. Thetrocar 33 is then removed and replaced with a drill 35, as shown in FIG.27. While the cannula 34 is held stationary on the bone 38, a hole isdrilled into the bone 38, with depth predetermined by the bone stop 36and cannula stop 37, as indicated in FIG. 25. FIG. 28 shows the cannula34 held stationary, while the drill 35 is replaced with the fastenerdelivery device 73 set out-of-phase and inserted into the bone hole.

Unlike the collar fasteners 13 mentioned earlier, the gripping elements14 for the bone 38 attachment are designed to resist vertical orlongitudinal pull out. The length of the fasteners 13 is sufficient tospan the depth of the drilled hole to beyond the collar of the torn ACL28, depicted in FIG. 24. Prior to deployment of the fasteners 13, thecannula 34 is lifted beyond the slit 2 of the needle 1, as shown in FIG.29. The collagen fibers of the ACL 28 are in contact with the deliverydevice 73, especially with the slit 2 portion of the needle 1. The firstfastener 13 is then deployed.

FIG. 30 depicts the gripping of three deployed fasteners 13 after thewithdrawal of the fastener delivery device 73. The distal portion of thefasteners 13 in the cone-shaped bone hole tightly grip and anchor thebone 38. The proximal portion of the fasteners 13 grip thecollar-fortified ACL 28 fibers. Due to the spring-like property builtinto the fastener body 13, the gripping elements 14 at both portions areconstantly compressing the tissues, in this case the ACL 28 fibers andbone 38, making the fastening strength exceptionally strong. To ensureadequately strong reattachment, multiple fasteners 13, preferablydeployed in different directions, can be loaded into the same drilledhole without completely lifting the fastener delivery device 73.

For deployment of multiple fasteners 13, the device 73 in the puncturesite 32 is reset to the out-of-phase mode. As mentioned, it is possiblethat a portion of the deployed fastener 13 may remain in the cartridge 7and restrict the cartridge 7 from rotating back to the out-of-phasemode. To free the cartridge 7 from the deployed fastener 13, the device73 may have to be slightly withdrawn from the puncture site 32 to departor be free from the deployed fastener 13 prior to rotation. Anotherfastener 13 may then be advanced to the deploy position within thecartridge 7. The device 73 is rotated slightly to alter the direction ofthe next fastener 13 deployment This procedure is repeated until thetorn 22 ACL 28 is tightly fastened onto the bone 38.

Often, the ACL 28 is torn at or near its mid-section. A similartechnique with the ligament holder 29 and collar fasteners 13 is used toinstall two sets of collars, one on each torn end of the ACL 28. Theplacements of these collar fasteners 13 also are determined aftermanipulating and fitting the ACL 28 fragments in the patient's leg toensure appropriate length after reconnecting the ACL 28.

To attach two collar fortified ACL 28 fragments, the needle 1 isinserted through both sets of collars, bridged by the indented slit 2.Distally semi-deploying the first fastener 13 may be helpful to pull andmanipulate the distal ACL 28 fragment into place. Sliding the sleeve 18over the needle 1 can also be used to push tissue, in this case theproximal ACL 28 fragment, to tightly rejoin the ACL 28 fragments. Thefastener 13 is then fully deployed, gripping both fragments of ACL 28fibers fortified by two sets of collars 13. Due to the high tensilestrength required during normal function of the ACL 28, adding multiplefasteners 13 is recommended to ensure a successful ACL 28 repair.Therefore, after the initial fastener 13 deployment, the device 73 isreset to out-of-phase mode, another fastener 13 is advanced, and thedevice 73 is rotated to deploy another fastener 13. The procedure isrepeated until the two ACL 28 segments are firmly reattached by thedeployed fasteners 13, as shown in FIG. 31. Again, it is possible that aportion of the deployed fastener 13 may remain in and restrict therotation of the cartridge 7. A slight withdrawal of the device 73 may benecessary before resetting it to the out-of-phase mode.

In alternate methods, the collar fasteners 13 may be tied with suturesto another set of collar fasteners 13, to a tunnel through the bone 38,a bone anchor, etc.

By fortifying and reattaching the torn ACL 28 with fasteners 13, thepatient has avoided the trauma of replacement harvesting and extensivebone drilling required by conventional ACL 28 repair.

(C) Tendon Repair

A tendon 40 torn from the bone 38 is common among sport injuries andaccidents. Generally, there are two major approaches for reattaching atendon 40 back to the bone 38. The traditional repair is to drillthrough the bone 38, then pass a suture to attach the torn tendon 40back to the bone 38. Recently, tendon 40 repair has been done using lessinvasive drilling and artificial bone anchors with attaching sutures,which are fitted into a shallowly drilled hole in the bone 38. Even withbone anchors, suture manipulation requires both time from surgeons andsurgical space within the patient, which may lead to large or multipleincisions.

Similar to reattaching the ACL 28 to the bone 38, a trocar 33 is used topierce and guide the tendon 40 into proper position, where a hole willbe drilled in the bone 38. A cannula 34 is inserted over the trocar 33,and then the trocar 33 is replaced with a drill 35 creating a hole inthe bone 38. The drill 35 is then replaced by the fastener deliverydevice 73 inserted through the tendon 40 into the bottom of the bonehole. The cannula 34 is lifted so that the slit 2 opening of the needle1 is in contact with tendon tissue 40. If necessary, the tendon 40 canbe pushed and positioned by the sliding sleeve 18. The fasteners 13 inthe device 73 should have sufficient length to grip both the bone 38 andthe tendon tissue 40. With time, similar to the reattached ligament, thetendon 40 can and most likely will permanently reattach back onto bone38.

For soft bone, such as the humerus 39 in the shoulder, the needle 1 ofthe device 73 could possibly pierce a tendon 40 to be reattached andpuncture into the humerus 39 without using the trocar 33, cannula 34 anddrill 35. FIG. 32 depicts a tendon 40 torn from the humerus 39. Thefastener delivery device 73 can be inserted through a small opening andguided by an endoscope to reattach a tendon 40 back to the humerus 39without suture sewing, manipulating or tying.

FIG. 33 shows how a surgeon can use the sleeve 18 to push and positionthe tendon 40 back to the humerus 39 endoscopically. Similar to the ACL28 repair indicated in FIG. 30, the fasteners 13 should be long enoughto extend from the hole pierced in the humerus 39 to the tendon 40tissue. After the tendon 40 has been positioned, the fastener 13 isdeployed to anchor the tendon 40 back to the humerus 39. The deviceoperation is similar to that previously described. Multiple fasteners 13can be deployed to fly fasten the ruptured tendon 40.

(D) Bulging or Herniated Disc Fastening and Repair

Low back pain from bulging or herniated discs 41 is one of the mostprevalent, painful and debilitating ailments afflicting mankind. Asmentioned, treatments ranging from the traditional to the percutaneousapproaches all have their drawbacks, some are very serious. All theseapproaches have one thing in common: tissue removal. Vastly differentfrom the tissue removing procedures, the methods described herein usevarious techniques and devices to fasten the bulging or herniated disc41 to alleviate nerve 25 impingement

To fasten a bulging or herniated disc 41, the spring-like fasteners 13of the invention are made extra long with multiple gripping elements 14.FIG. 34 depicts a long fastener 13 with a spring-like or shape memoryelement 15 and multiple gripping elements 14 on both ends. This type offastener may be suitable for intervertebral use, especially forfastening bulging or herniated discs 41 of the spine.

FIG. 35 depicts a nerve retractor 51 lifting an impinged nerve 25 awayfrom a bulging or herniated disc 41. A delivery device 73 is loaded witha fastener 13 similar to the one in FIG. 34. For the best result, theneedle 1 of the fastener delivery device 73 punctures the bulgingportion and is guided into the disc 41 by anteroposterior and lateralfluoroscopy or other technique. In cases where the bulging portion ofthe disc 41 is well concealed by the lamina of the vertebra, a smallamount of the bone can be removed to allow penetration of the deliverydevice 73.

To prevent possible leakage of the nucleus pulposus around the fastener13, prior to device 73 insertion into the disc 41, an optional sealingpatch 43, made with elastic and biocompatible material with closurecapability, may be inserted on the needle 1 near the proximal portion ofthe needle slit 2. For best results, the sleeve 18 is fixed proximallyand stationary to provide a position where the proximal tip of the soonto be deployed fastener 13 will grip the sealing patch 43. Using similarguiding, inserting and compressing techniques, the sealing patch 43 istightly compressed, adhered or maybe even embedded into the previouslybulging or herniated annulus 41. As the fastener 13 is deployed, itgrips the patch 43 to seal possible leakage of nucleus pulposus.

FIG. 36 depicts the compression of the bulging disc 41 and the optionalsealing patch 43 around the sleeve 18, when the appropriate depth isreached. While compression continues, the fastener 13 is deployed togrip and compress the previously bulging tissue back in place as shownin FIG. 37. To make possible the push and hold technique using thesleeve 18 during deployment of the fastener 18, the distal end of thesleeve 18 also contains a slit 19, which overlaps the slit 2 of theneedle 1. As the device 73 is set in the in-phase mode, all three slits2, 8, 19 of the needle 1, cartridge 7 and sleeve 18 are aligned,allowing the fastener 13 to deploy and hold the compressed tissue inplace. When applied prior to fastener deployment, the sealing patch 43is also compressed against the bulging disc 41. The sealing patch 43 ismade with elastic and conforming material capable of sealing potentialleakage of nucleus polposus. However, the annulus may be self-sealingwith no significant leakage of nucleus pulposus. Therefore, the sealingpatch 43 is optional.

Once the device 73 has been withdrawn, as shown in FIG. 38, the fastener13 remains within the disc 41 with constant gripping and fasteningforces maintained and substantiated by the spring-like or shape memoryelement 15, thereby holding back the previously bulging annulus 41.

Similar to previously mentioned surgical procedures, more than onefastener 13 can be deployed through the puncture site 32, preferablytoward different directions, to enhance a permanent fastening. Thespring-like fasteners 13 with multiple gripping elements 14 provide anexceptionally strong holding strength, away from nerves.

FIG. 39 depicts the sealing patch 43 gripped by the proximal portion ofthe fastener 13 outside the repaired annulus, not shown. The mainfunction of the sealing patch 43 is to prevent possible leakage of thenucleus polposus. The preferred materials used in constructing the patch43 are silicone rubber, elastic polymer or biomaterial. Polyurethane orother material can be added or sandwiched to strengthen the sealingpatch 43. However, the sealing patch 43 is optional, and the fastener 13can be deployed entirely within the disc, without protrusion.

For fastening bulging discs 41, devices other than the fastener deliverydevice 73 can be used. FIG. 40 shows an alternate device using a discfastening screw 44 with variably pitched threads 63 designed to compressand fasten the bulging annulus. The screw 44 may be inserted directly inthe disc 41 or a pre-punctured hole may be used. A washer 45 containinga locking nub in conjunction with the locking teeth 64 preventsloosening of the screw 44.

A needle puncturing a bulging disc may be guided by a three-dimensionalviewing technique as mentioned, creating an entry for the disc fasteningscrew 44. After the withdrawal of the needle, the screw 44 enters tofasten the previously bulging disc 41, as shown in FIG. 41. The optionalsealing patch 43 can be used in conjunction with the screw 44 and washer45.

Sutures 21 can also be used to fasten a bulging or herniated disc 41.Sutures 21 may be made of natural materials, such as gut, polymers, suchas polyester, nylon and PTFE, or metals, such as stainless steel. FIG.42 depicts another bulging or herniated disc fastening device using asuture 21 tied to the midsection of a dumbbell shaped rod 47. The rod 47with suture 21 is fitted inside a spinal needle 46. Behind the rod 47, aplunger 48 is inserted into the spinal needle 46. FIG. 43 depicts theassembly of the rod 47, suture 21 and plunger 48 inside a spinal needle46.

FIG. 44 depicts a guided puncture using the spinal needle 46 containingthe assembly of the rod 47, suture 21 and plunger 48, as indicated inFIG. 43, through the bulging or herniated disc 41. To avoid potentialdamage to vessels, nerves or other tissue, the protrusion of the distaltip should be minimal. With the plunger 48, the rod 47 is pushed out ofthe distal opening of the spinal needle 46, outside the annulus asindicated in FIG. 45.

The rod 47 is now caught by the outer surface of the annulus and acts asan anchoring device for the suture 21. The spinal needle 46 is removed,as shown in FIG. 46. A washer 49 is threaded with the suture 21, slippeddown to the bulging disc 41, compressed and tied. For surgicalconvenience, the washer 49 can be made in conjunction with asuture-locking device to eliminate suture tying. The thickness of thewasher 49 should be minimal to minimize potential contact and irritationof any adjacent nerves. The suture holes in the washer 49 should be asclose as possible to avoid substantial spreading of the suture 21.Suture 21 spreading may create a passage for leakage of nucleuspolposus. The optional sealing patch 43 can be used in conjunction withthe washer 49.

FIG. 47 shows the previously bulging disc 41 compressed by the washer 49and fastened by a suture knot 50. To avoid potential irritation of thenerve 25 by the suture 21, the exposed suture 21 should be trimmed nearthe suture knot 50.

Depending on the severity of the bulge or herniation, a simple staple 78or tack with tissue holding elements may be sufficient to fasten theweak annulus. FIG. 48 depicts a staple 78 with annulus-holding barbs 79.For minor bulging, the simple staple 78 may be sufficient to fasten thebulge. If needed, the legs of the staple 78 can be made significantlylonger than the ones depicted in the drawing. FIG. 49 depicts anothertype of staple 78 with shape memory legs 80 to hold and fasten a bulgingdisc 41. The shape memory legs 80 of the staple 78 can also be madesignificantly longer than the ones depicted in the drawing.

Since the guiding techniques for inserting fasteners into the bulging orherniated discs 41 are similar to the ones used in relatively low riskpercutaneous nuclectomy procedures and routine diagnostic discographyfor determining herniation, the methods used in fastening bulged orherniated discs 41 should also be low in risk and complications.

The depth of the device penetration, the overall length of the fasteners13, and direction of fastener 13 insertion are related and are veryimportant issues in fastening bulging or herniated discs 41. The nucleuspulposus in the central portion of the discs 41 is unlikely to beeffective in gripping. With the information provided by discography orother diagnostic techniques, healthy annulus around the bulge or acrossthe nucleus pulposus can be used to anchor the fasteners. To preventpossible contact between fasteners and nerves 25 or other tissues,protrusion of the deployed fasteners outside the disc 41 is preferred tobe minimal or absent. For example, the fastener 13 may be deployedwithout entirely piercing through the opposite wall of the disc 41 sothat only a single puncture is made, or the fastener 13 may be deployedentirely within the disc 41 such that once the delivery device 73 isremoved there are no protrusions from the wall of the disc 41.

Some surgeons may like to approach the disc repair anteriorly. Afterretracting the abdominal contents, the fastener delivery device 73 canbe guided, perhaps by fluoroscope or other means, through the disc 41 tothe bulging or herniated portion. As the tip of the device reaches ornears the bulging surface, the distal half of the fastener 13 isdeployed. The bulging portion of the disc 41 is gripped and pulledinward, then the fastener 13 is totally deployed to fasten the bulgingdisc 41. Although the anterior approach is possible, the posteriorapproach usually reaches the bulge more directly and is preferred.

Unlike the tissue removing approaches of percutaneous nuclectomy,chymopapain digestion or discectomy, fasteners in general directly,actively and/or elastically hold the bulging or herniated tissue backwithout removing the nucleus pulposus, the essential component tosustain prolonged compression when upright, and resiliently re-inflateand re-establish disc height when at rest. Therefore the bulging orherniated disc 41 may be repaired without loss of the disc 41 or nucleuspulposus.

(E) Urinary or Fecal Incontinence Repair

For the sufferers of urinary or fecal incontinence, the inconvenienceand social problems are often too great to ignore, but the treatmentoptions are far from ideal. The options range from ineffectiveinjections to open surgeries with possible serious complications. Withoptions such as these, it is no wonder that over $400 million is spenteach year on adult diapers (Colon, Rectum and Anus, 2nd Ed., PhilipGordon, M.D., et. al., 1999).

FIGS. 50-54 show the fasteners 13 deployed or being deployed toelastically grip or close passages within the body to alleviate urinaryand fecal incontinence. For urinary incontinence, the sphincter urethraeor the urethra itself are possible sites for fastening. For fecalincontinence, the rectal sphincter 54 is a potential site for fastener13 deployment. Fasteners 13 may also be used to resiliently close therectum, anal canal or other passages within the body. As the pressurefrom the bladder 53 or colon increases, the elastically fastenedsphincters 54 open to allow passage of contents. After the contents areemptied, the pressure decreases and the sphincters 54 are againelastically closed by the resiliently curved fasteners 13. For patientswith no neurological problems, the elastically fastened sphincters 54may also be opened by voluntary muscles.

Regarding the insertion of the fastener delivery device 73, numerousexisting guiding techniques, such as cystoscope, ultrasound,anteroposterior-lateral fluoroscopy, MRI, or others, can be usedeffectively and accurately to guide the insertion and deployment of thefasteners 13. Again, multiple fasteners 13 can be used to ensure properclosure of the sphincter 54.

FIG. 50 depicts an insertion of the fastener delivery device 73 into aleaking anal sphincter 54. When a fastener 13 is deployed, the fastener13 elastically grips and closes a portion or the entire leaky opening ofthe sphincter 54.

FIG. 51 depicts a deployed fastener 13, indicated by the dottedcurvature, around the anal sphincter 54. The device 73 is reinsertedinto another portion of the sphincter 54 to deliver another fastener 13.Although other orientations may be used, in this example, the deviceentries are approximately 90° to each other.

FIG. 52 depicts an elastic closure of the anal sphincter 54, in thiscase with two spring-like fasteners 13 under the skin.

FIG. 53A depicts a sphincter 54 leaking due to incomplete closure. Thesphincter 54 can be urinary or fecal.

FIG. 53B depicts the partial closure of the sphincter 54 by aspring-like fastener 13. In this example, the fastener 13 has very fewgripping elements 14 to minimize irritation of nerves around thesphincter 54.

FIG. 53C depicts the elastic closure of the sphincter 54 by twospring-like fasteners 13.

Especially among elderly patients, the elasticity or the resiliency ofthe sphincter urethrae and/or the rectal sphincters varies greatly.Before inserting the fastener delivery device 73, elasticity orresiliency sensing instruments can be used to determine the closingpressure of the sphincter prior to selecting fasteners 13 withappropriate gripping forces, closure strengths and curvatures suitablefor individual patients.

FIG. 54 depicts possible entries for the fastener delivery devices 73for treating urinary and fecal incontinence. Three-dimensional guidinginstrumentation may be required, especially for urinary closure. Toprovide instant feedback to the surgeon, a pressure sensing catheterballoon, strain gauge, or tightening detecting instrument 55 can beinserted into the leaking portion of the rectum and/or urethra As thefastener 13 deploys and tightens the leaking portion, the instrument 55can provide instant information to the surgeon regarding the closingpressure, placement and effectiveness of the deployed fastener 13. As aresult of properly deployed fasteners 13, the elastic closure of theurethra and/or anal canal can provide instant and probably long lastingimprovement to incontinence problems.

For fluoroscopic image enhancement, the catheter or instrument 55 can bemade or coated with radiopaque material to perfect the accuracy of thefastener delivery device 73 insertion. For ultrasound image enhancement,echogenic enhancing material can be used. Similarly, the needle 1 of thefastener delivery device 73 can also be coated with image enhancementmaterial, such as radiopaque, echogenic, etc., for even more accuratedevice 73 insertion.

The delivery of spring-like fasteners 13 is considered minimallyinvasive and a low risk procedure. The benefits, however, can be longlasting and comparable to or exceeding the results of open surgery.Furthermore, both the device 73 and the fasteners 13 probably would notinvade the inner lining of the sphincter 54 or contact potentiallycontaminated waste material. Therefore, infection and othercomplications may be significantly minimized.

(F) Carpal Tunnel Syndrome Relief

Repetitive strain injuries have become more and more common. Aparticularly common and debilitating form is carpal tunnel syndrome.Many who suffer from carpal tunnel syndrome depend on their manualdexterity to perform their jobs. Prolonged or frequent restrictions ofhand and wrist movement pose significant problems in their jobperformances. Surgical relief by cutting the flexor retinaculum 57 todecompress the median nerve seems to be too drastic and may lead tocomplications.

FIG. 55 depicts a hand with carpal tunnel syndrome and insertion of afastener delivery device 73 into the flexor retinaculum 57, not shownunder the skin, guided by penetration markers 3 or other devices. Thefasteners 13 are deployed within the retinaculum perpendicular to andover the median nerve and toward the palm. With the elastic curvature ofthe fastener 13 and the pliable nature of the flexor retinaculum 57, thecurvature of the fastener 13 forms the shape of an arch, lifting theflexor 57 tissue, which was compressing the median nerve. FIG. 56depicts several fasteners 13 deployed toward the palm lifting thecentral portion of the flexor retinaculum 57, creating a tunnel or anarch to accommodate the irritated median nerve without cutting theflexor retinaculum 57. The fasteners 13 can even be made withbiodegradable materials, which degrade with time after relieving thepain and inflammation.

(G) Double Indented Needle Slit for Versatile Tissue Manipulation andInterlocking Fasteners

Depending on the surgical needs, sometimes the proximal half 77 of thefastener 13 can provide better assistance in tissue manipulation thanthe distal half 76 of the fastener 13. It is possible to open the slit 2in ways to allow the deployment of either the distal portion 76 or theproximal portion 77 of the fastener 13 in semi-in-phase mode. One sideof the slit 2 is indented at the distal half 74 while the other side ofthe slit 2 is indented at the proximal half 75, as indicated in FIG. 58.Depending on the direction of cartridge 7 rotation, relative to theneedle 1, the semi-in-phase mode can bring out either the distal end 76or the proximal end 77 of the fastener 13. Tapered fastener holdingelements 60 may cover and support both semi-deployments.

To enhance the double indented feature of the needle slit 2, thecurvature of the fasteners 13 can be made asymmetrical, as shown inFIGS. 57A and B. For example, the first fastener 13 in the deployposition is made with a curvature near the proximal end 77 of thefastener 13, as shown in FIG. 57A. The following fastener 13 in thecartridge 7 is made with a curvature near the distal end 76 of thefastener 13, as shown in FIG. 57B. After semi-deploying the proximalhalf 77 of the first fastener 13, the tissue is tightened by pushing,then fully deploying the first fastener 13. The device 73 is slightlywithdrawn and reset to out-of-phase. The following fastener 13 isadvanced into the deploy position. The distal portion 76 of the secondfastener 13 is semi-deployed into the tissue. Instead of tissuetightening by pushing as indicated with proximal deployment, the distalsemi-deployment requires pulling of the device 73 to tighten the tissuebefore full deployment With tissue tightening by pushing and pulling,the fasteners 13 interlock the tissue, through one needle 1 puncture.Other than pushing and pulling on the semi-deployed fasteners 13,twisting provides yet another dimension and benefit to the tissuemanipulation and interlocking fastening.

The double indented needle slit 2 and the fasteners 13 with asymmetricalcurvature can be utilized to clamp arteries, restrict sphincters,reattach tissue or other uses.

(H) Tumor Artery Closure

A tumor 56 demands far more nutrients than normal tissue. Cutting thearterial 23 blood supply may slow the growth or even diminish the sizeof a tumor 56 prior to surgical removal. With an angiogram, the locationof the arteries 23 supplying die tumor 45 is mapped out. FIG. 59 depictsthe fastener delivery device 73 inserted and guided to a tumor-feedingartery 23. With the needle slit 2 facing the artery 23, the proximalportion 77 of the fastener 13 is deployed under the artery 23. Thedevice 73 may then be gently pushed to compress and restrict the artery23. While pushing, the fastener 13 is fully deployed to clamp andrestrict the artery 23.

FIG. 60 depicts the fully deployed fastener 13 from the proximalsemi-deployment. The device 73 is slightly withdrawn, reset and advancedwith another fastener 13 from the cartridge 7. The second fastener 13 issemi-distally deployed over the artery 23. The device 73 may then begently pulled to hook and further restrict the artery 23. While pulling,the second fastener 13 is fully deployed to shut the blood flow. Morefasteners 13 can be deployed to ensure a complete closure of the artery23 feeding the tumor 56.

FIG. 61 depicts both fully deployed inter-locking fasteners 13restricting blood flow to the tumor 56. In this example, the figuresindicate pushing and pulling actions of the device to restrict thevessel. Twisting or rotating the semi-deployed fasteners 13 to createkinks on the vessels can also provide exceptional closure of the vessel.Also, more fasteners 13 can be deployed along the artery 23.

(I) Additional Embodiments

Fasteners 13 are frequently used in or near joints, tendons 40,ligaments or sphincters 54, where tissue movements are routine. Movementcan shift the fastener and cause it to migrate. Fastener migration israrely desirable. In fact, it can be quite damaging, especially when thefastener migrates into joints, nerves 25 or vessels. For sphincter 54repair, migration can negate the corrected closure of the dysfunctionalsphincter 54.

FIG. 62 depicts a fastener 13 with tissue ingrowth holes 4 to minimizepossible fastener 13 migration. The holes 4 can also be in the flexibleor shape memory element 15.

FIG. 63 depicts another fastener 13 with tissue ingrowth grooves 5designed to minimize fastener 13 migration. The grooves 5 can also be inthe flexible or shape memory element 15.

FIG. 64 depicts a suture 21 attached to a fastener 13 with grippingelements 14 and spring-like or shape memory element 15. The fastener 13can be used as a suture anchor, holding the suture 21 for tissueattachment. This type of suture anchor can be used for cosmetic surgerywith minimal incision.

The fastener delivery device 73 utilizes the mating cartridge 7,relative to the needle 1, to deploy fasteners 13 into tissue throughoverlapping slits 2, 8. Similar fasteners 13 can be resilientlystraightened in a spinal needle 46 without the cartridge 7. Instead, aplunger 48 is fitted inside the spinal needle 46 behind the fastener 13,as shown in FIG. 65. After insertion of the needle 46 into tissue, theplunger 48 is held stationary while the needle 46 is slowly retracted orwithdrawn from tissue, thereby deploying the fastener 13 out of thedistal opening of the needle 46. In tissue, the fastener 13 resumes theoriginal resilient curvature and tightly fastens onto the tissue.Multiple fasteners 13 can also be loaded into the needle 46 and deployedone at a time into different locations.

FIG. 66 depicts an exploded view and FIG. 67 an assembled view of amodular fastener 13. The modular gripping elements 14 mount intooptionally recessed areas or pockets of a fastener 13 secured by stems71, which tightly fit into gripping element holes 72. Due to thepressure exerted by the spring-like or shape memory element 15, themodular gripping elements 14 are not free to be lifted off from the mainfastener body in the delivery device 73 or in tissue after deployment.

Modular gripping elements 14 can be extremely useful in some surgicalrepairs. For example, anal sphincter 54 fastening for fecal incontinencemay adversely affect nerves 25 and blood vessels surround analsphincters 54. It may be difficult to fasten just the nerve-free portionof the sphincter 54. The gripping elements 14 of the fastener 13 mayirritate nerve fibers after the deployment of the fasteners 13. However,the gripping elements 14 are essential for anchoring the long-lastingfasteners 13 in place. With biodegradable modular gripping elements 14,the elements 14 degrade away after the fasteners 13 have been securedand tissues have grown into the tissue ingrowth holes 4 or grooves 5 (asshown in FIG. 63). Irritation of the nerve is then minimized with theremaining portion of the long-lasting elastic fasteners 13 gripping thesphincter 54.

For other surgical purposes, instead of relying on the gripping elements14 to secure the fastener 13, the modular portion of the grippingelements 14 can be replaced with high friction coefficient materialssuch as silicone rubber or with tissue adhesives.

FIG. 68 depicts a needle slit 2 formed with a smooth and round curvatureto minimize puncture resistance. With clockwise cartridge 7 rotation,the depicted smooth indentation accommodates distally semi-deployedfastener 13.

FIG. 69 depicts a needle slit 2, which is slanted. As the cartridge 7and fastener 13, both not shown, rotate counter-clockwise, the distalportion of the fastener 13 would initially deploy out of the slantedneedle slit 2. For clockwise rotation, both distal and proximal portionsprotrude out of the needle 1 while the middle portion of the fastener 13remains in the needle 1. With tissue gripping by both distal andproximal portions of the fastener 13, extra tissue manipulative power isprovided to the surgeon prior to complete fastener deployment.

FIG. 70 depicts an exploded view and FIG. 71 an assembled view of amodular fastener 13. The modular arm 67 has a connecting stud 69extending from the end. A connecting hook 70 also extends from themodular arm 67 adjacent the connecting stud 69. The connecting stud 69and connecting hook 70 are placed within a connecting hole 68 within theshape memory element. The connecting hook 70 extends into a matinglocking notch within the connecting hole 68, thereby locking the partsof the modular fastener 13 together.

Modular arms 67 can provide benefits which a single piece fastener 13may not cover, especially when the arms 67 are made with differentmaterials, size, shape, curvature, physical treatment or others. Forexample, the bulging portion of the annulus requires extra tension fromthe fastener 13 to retain the bulge. If the whole fastener 13 were madewith a high tensile strength material, the whole disc would be adverselypinched out of shape by the fastener 13. However, with modularcapabilities, the bulge-retaining arm 67 can be made with high tensilestrength material while the anchoring arm is made with a lower strengthmaterial. As a result, the bulging annulus is retained without pinchingthe entire disc.

For tissue attachments into thin bones, insertion of permanent fasteners13 can weaken the bone and may even cause future fracture from excessiveload. To prevent bone weakening, biodegradable arms 67 and grippingelements 14 can be used to insert into bones, while the remainingportion of the fasteners 13 can be made with strong and permanentmaterial.

To optimize fastening capability in some special surgical repairs, onearm 67 can be made with elastic material and the other arm 67 can bemade with shape memory material.

For fasteners 13 made with a significant curvature, modular componentsor composition may relieve the strain of the fastener 13.

Modular components, such as the gripping elements 14, arms 67 andspring-like or shape memory element 15, of a fastener 13 can providenumerous benefits and greatly improve fastening performance. Thecomponents can be made with different materials, curvature,degradability, biocompatibility, hardness, tensile strength, tensilemodulus, modulus of elasticity, size, friction coefficient, transitiontemperature, transformation temperature, torsion, other physical,chemical or biological characteristics. In addition to the depictedconnecting means for assembling the modular components, numerous othermethods and configurations can be used for a functional fastener 13.

FIG. 72 shows the back line 66, indicated by dots, as the otherorientation line on the needle 1 which indicates direction of the backof the deploying fastener 13.

FIG. 73 depicts a curved needle 1. For hard to reach repair sites, acurved needle 1 can allow the surgeon to access and fasten the repairsite hidden behind or around adjacent tissues. Similarly, a curvedneedle 1 can penetrate under the skin or tissue for fastening orclosure.

To accommodate cartridge 7 rotation in the curved needle 1, flexiblemetal, such as nickel-titanium, or flexible polymer can be used toconstruct the cartridge 7. Other embodiments could use a counterwound orbraided torque cable.

(J) Retrieval of Deployed Fastener

As with any other surgical procedure, mistakes can occur with fastener13 deployment. Fortunately, the deliveries of fasteners 13 described inthis invention are minimaly invasive. As long as the incorrectlydeployed fastener 13 does not pose problems or cause discomfort to thepatient, the incorrectly deployed fastener 13 can be left in place.After learning from the error, one can then correctly deploy anotherfastener 13.

Some incorrectly deployed fasteners 13 can cause problems for thepatients; those fasteners 13 should be removed. The best way to removethe sustained gripping fastener 13 is to endoscopically cut themid-section of the fastener 13 before pulling each section out of thepatient. If the retrieval of the problematic fastener 13 is toodifficult or even impossible through an endoscopic approach, an opensurgery may be necessary. Although incorrect deployment happens, thefasteners 13 and the delivery devices 73 mentioned in this inventionprovide superior control for the surgeons during the procedures andoutstanding results for the patients when the fasteners 13 are properlydeployed.

(K) Accessibility of the Fastener Delivery Device

In addition to the sustained gripping property of the fastener 13 andthe versatility of the delivery device 73, another major benefit to thisinvention is that with proper guiding techniques, the device 73 candeliver the fasteners 13 deep into the body of the patient The needle 1of the device 73 can be curved with a flexible cartridge 7 toaccommodate rotation within the curved needle 1 to reach around organsand tissue into a target site.

Many other surgical procedures can utilize the fastener 13 and thedelivery device 73. Some examples follow. The fastener 13 and deliverydevice 73 can endoscopically attach dislocated organs. For weight losspurposes, fasteners 13 can be used to slow stomach emptying byrestricting the pyloric sphincter or pyloric canal. The fasteners 13 canalso be used to attach medical devices inside the body.

The fastener 13 and the delivery device 73 can serve in numerousendoscopic procedures, which require connecting, reattaching, holding,fortifying, restricting, closing, compressing or decompressing tissuesor other devices.

In brief summary, the possible benefits of the sustained grippingfasteners 13 and the delivery device 73 include: (1) grip tissuecontinuously, (2) minimize fastener migration, (3) minimally invasive,(4) deploy multiple fasteners within a puncture site, (5) access deepbody targets, (6) support and fortify fragile tissue, (7) reattachtissue without suturing, (8) attach tissue to bone, (9) require minimalsurgical space, (10) attach to other fastening devices, (11) versatile,(12) provide permanent and/or degradable fastening, (13) simple to use,(14) manipulate tissue, (15) restrict or close orifices or vessels, (16)compress or decompress tissue, and (17) provide directional fastening.

(L) Materials and Designs

The needle 1 of the fastener delivery device 73 is preferred to be madewith stainless steel. Other alloys, metals, polymers, graphitecomposites, ceramics, or other materials can also be used. For tissuepuncturing, the distal opening 16 of the needle 1 is sharpened or shapedinto various configurations appropriate for the need. Normally, theneedle 1 is made straight. But for hard-to-reach surgical sites, theneedle 1 can be made curved with a flexible cartridge 7 to accommodaterotation in the curved needle 1. Penetration markers 3, a deploy line 65and a back line 66 can be printed or etched on the surface of the needle1. Lubricating coatings, such as silicone oil, plasma coating, PTFE orothers, can be applied inside the needle 1 to decrease friction duringthe operation of the fastener delivery device 73. The lubriciouscoatings can also be used on the outside of the needle 1 to ease thetissue penetration.

To enhance the guiding capabilities of the needle 1 into tissue, theneedle 1 can be coated with radiopaque, ultrasound echoing or otherimage-enhancing material.

The needle body 61, handle 6 and cartridge cap 58 can be made withpolymers, metals, other materials or combinations thereof.

Stainless steel is the preferred material for making the sleeve 18,although other materials, such as polymers or other metals can be used.To fit over the curved needle 1, flexible materials, such as nickeltitanium or polymers, are more suitable materials for making the sleeve18. Likewise, the sleeve handle 20 can also be made with stainlesssteel, polymers or other metals.

Similar to the preferred material used for making the needle 1, thecartridge 7 is also preferred to be made with stainless steel, butmaterials, such as other metals, polymers, graphite composites, ceramicsor others, can also be used. If the needle 1 is curved, the cartridge 7material should be flexible enough to accommodate the rotation in thecurved needle 1. Nickel titanium alloy is a strong and flexible metal,which may be suitable for making the flexible cartridge 7.

Both slits 2, 8 of the needle 1 and cartridge 7 are wider than the widthof the fasteners 13. The length of the cartridge slit 8 may differ fromthe length of the needle slit 2. In fact, the length of the cartridgeslit 8 can open longitudinally along the cartridge 7, as a trough. Theopen trough may provide several major benefits. The trough can serve asrailings to align and maintain the fasteners 13 to face a certaindirection. The opening of the trough provides more space to decreasestress and strain on the resiliently straightened fasteners 13, and itaccommodates larger fasteners 13, which otherwise would not fit in atube-like cartridge 7. The length and configuration of the cartridgeslit 8 can be further modified depending on the material used toconstruct the cartridge 7 and on the requirement of the fasteners 13. Alubricious coating can be applied especially on the inside wall of thecartridge 7 to decrease friction during advancement of the fasteners 13.

The simple fastener-advancing unit consists of a plunger 10 driven byscrew action of the advancing device 11 with a handle 12. Ideally, thepitch of the screw is spaced out precisely so that each turn or half aturn on the handle 12 advances a fastener 13 into the deploy position.Other advancing devices and mechanisms can also be used. The materialused in the fastener-advancing device can be metal, polymer, ceramic orcombinations of these.

The fastener delivery device 73 can come conveniently loaded with one ormore fasteners 13 in the cartridge 7 chamber. However, with somemechanical or temperature assistance, it is not prohibitively difficultto load fasteners 13 into the cartridges 7 in the surgical room.

It should be clear to one skilled in the art that the currentembodiments, methods and surgical sites are not the only uses for whichthe invention may be used. Different materials for the needles,cartridge, bodies, handles, fasteners and other components can be used.The use of this invention is also foreseen to repair, fasten, close orrestrict various tissues, such as canals, organs, vessels, tendons,ligaments, muscles, cartilage, skin, bone, valves, prostheses, cosmeticlifts, tissue grafting, and other surgical procedures. Nothing in thepreceding description should be taken to limit the scope of the presentinvention. The full scope of the invention is to be determined by theappended claims.

APPENDIX A NUMERICAL REFERENCES IN DRAWINGS Needle 1 Slit of needle 2Penetration markers 3 Tissue ingrowth hole 4 Tissue ingrowth groove 5Needle handle 6 Cartridge 7 Slit of cartridge 8 Cartridge handle 9Fastener-advancing plunger 10 Fastener-advancing device 11Fastener-advancing handle 12 Fastener 13 Gripping elements 14Spring-like or shape memory element 15 Needle distal opening 16Cartridge distal opening 17 Sleeve 18 Slit of sleeve 19 Sleeve handle 20Suture 21 Torn tissue 22 Artery 23 Vein 24 Nerve 25 Meniscus 26 Capsule27 Anterior cruciate ligament, ACL 28 Ligament holder 29 Device guidingtracks 30 Ligament holder handle 31 Puncture site 32 Trocar 33 Cannula34 Drill 35 Bone stop 36 Cannula stop 37 Bone 38 Humerus 39 Tendon 40Bulging or herniated disc 41 Spinal cord 42 Sealing patch 43 Screw 44Washer with locking snub 45 Spinal needle 46 Dumbbell shaped rod 47Plunger 48 Washer 49 Suture knot 50 Nerve retractor 51 Anus 52 Bladder53 Sphincter 54 Tightening detecting instrument 55 Tumor 56 Flexorretinaculum 57 Cartridge cap 58 Sleeve-sliding track 59 Tapered fastenerholding elements 60 Needle Body 61 Cartridge body 62 Variable pitchthread 63 Locking teeth 64 Deploy line 65 Back line 66 Arm 67 Connectinghole 68 Connecting stud 69 Connecting hook 70 Gripping element stem 71Gripping element hole 72 Fastener delivery device 73 Distal portion ofneedle slit 74 Proximal portion of needle slit 75 Distal portion offastener 76 Proximal portion of fastener 77 Staple 78 Barbs on staple 79Shape memory staple legs 80 Ligament holding device 81

We claim:
 1. A method of delivering a resilient fastener into human oranimal tissue to repair a bulging or herniated intervertebral disc, themethod comprising the steps of: (a) inserting a needle into the bulge ofthe intervertebral disc, said needle having at least one resilientfastener constrained in an extended, open position therein; (b)deploying said resilient fastener into the intervertebral disc; (c)causing said resilient fastener to move towards a predisposed clampingposition; (d) and withdrawing said needle.
 2. The method of claim 1further comprising the steps of: (e) passing said needle through theintervertebral disc; (f) compressing the bulge of the intervertebraldisc; (g) and deploying said fastener such that a first end of saidfastener extends from one side of the intervertebral disc and a secondend grips the bulge thereby maintaining the compression of the bulge. 3.The method of claim 2 wherein said second end extends at least partiallyfrom another side of said intervertebral disc.
 4. The method of claim 2wherein when said needle passes through the bulging or herniatedintervertebral disc, and said needle creates an opening, the methodfurther comprising the step of: (h) deploying a sealing member to sealthe opening in the bulging or herniated intervertebral disc.
 5. Themethod of claim 4 further comprising the step of: (i) deploying a secondsealing member to seal a second opening created at a distal end of thefastener.
 6. A method of delivering a fastener into a herniated orbulging intervertebral disc, the method comprising the steps of: a)compressing a bulge or herniation of the intervertebral disc; b) anddeploying a fastener into the intervertebral disc to hold the herniationor bulge in a compressed position.
 7. The method of claim 6 wherein saidfastener resiliently holds the herniation or bulge in the compressedposition.
 8. The method of claim 6 wherein said fastener device is ascrew and said screw is rotatably inserted into the intervertebral disc.9. The method of claim 8 wherein a washer is attached on an end of saidscrew.
 10. The method of claim 8 wherein said screw has a variable pitchthread, thereby allowing the user to compress the intervertebral disc assaid screw is rotated into the intervertebral disc.
 11. The method ofclaim 8 wherein said screw has a locking device to lock said screw inplace within the intervertebral disc.
 12. The method of claim 6 whereinsaid fastener device comprises a suture used to tie and compress thebulge in the intervertebral disc.
 13. The method of claim 12 whereinsaid suture is formed of metal.
 14. The method of claim 12 wherein saidsuture has an anchoring device.
 15. The method of claim 12 wherein awasher is tied to the intervertebral disc by said suture.
 16. The methodof claim 6 wherein said fastener is a tack which is pressed into thebulge.
 17. The method of claim 6 wherein said fastener is a staple whichis pressed into the bulge.
 18. The method of claim 6 wherein saidfastener is a clamp which is positioned around the bulge.
 19. The methodof claim 6 wherein said fastener is a tissue anchor used to press thebulging tissue against the intervertebral disc.
 20. A treatmentapparatus for compressing a bulge or herniation of an intervertebraldisc, comprising: at least one tissue holding element located proximatea first end of said treatment apparatus, compression means forcompressing the bulging or herniation of the intervertebral disc, saidcompression means being located proximate a second end of said treatmentapparatus, and a sealing patch for sealing an opening in saidherniation, wherein said first end is attached to said second end by amiddle portion.
 21. The treatment apparatus of claim 20 wherein saidmiddle portion is formed of a resilient material.
 22. The treatmentapparatus of claim 21 wherein said resilient material is a shape memorymaterial.
 23. The treatment apparatus of claim 20 wherein said at leastone tissue holding element is threading of a screw and said compressionmeans is a head located at a second end of said screw.
 24. The treatmentapparatus of claim 23 wherein said threading has a variable pitch. 25.The treatment apparatus of claim 23 further comprising a washer, whereinsaid washer is placed around a second end of said screw.
 26. Thetreatment apparatus of claim 25 wherein said washer further comprises alocking nub.
 27. The treatment apparatus of claim 26 further comprisinga sealing patch for sealing a herniation.
 28. The treatment apparatus ofclaim 26 wherein said sealing patch is elastic.
 29. The treatmentapparatus of claim 26 wherein said sealing patch is biocompatible. 30.The treatment apparatus of claim 20 wherein said treatment apparatus isa tack.
 31. The treatment apparatus of claim 30 wherein said at leastone tissue holding element is a barb on said tack.
 32. The treatmentapparatus of claim 20 wherein said at least one tissue holding elementis a ridge extending from a surface of said treatment apparatus.
 33. Thetreatment apparatus of claim 20 wherein said at least one tissue holdingelement is a rod and wherein said rod is attached to a suture which issized and configured to extend through at least a portion of the bulgingor herniated disc, said suture forming at least a portion of saidcompression means.
 34. The treatment apparatus of claim 33 wherein saidcompression means further comprises a washer.
 35. The treatmentapparatus of claim 20 wherein said at least one tissue holding elementis formed of a shape memory material.
 36. The treatment apparatus ofclaim 20 wherein said at least one tissue holding element forms a partof a fastener for holding tissue, said fastener having a first end, asecond end and a middle portion, said at least one tissue holdingelement located on said first end of said fastener, at least a portionof said fastener being formed of a resilient material, said resilientmaterial predisposing said fastener to form a curved or bent shape,wherein said fastener has an open position and a closed position,wherein in said open position, said fastener is configured to passthrough a generally cylindrical passage, wherein in said closedposition, said fastener assumes said curved or bent shape, said at leastone tissue holding element located on a concave side of said fastenerwhen said fastener is in said closed position, thereby grasping thetissue with said at least one tissue holding element.
 37. A deliverysystem for delivering a treatment apparatus, comprising: a treatmentapparatus, including: at least one tissue holding element, andcompression means for compressing the bulging or herniation of theintervertebral disc, and a fastener delivery device, including: ahollow, generally tubular needle having a distal end, a proximal end anda passage extending therethrough, a handle coupled with said needle, anda fastener deployment actuator coupled with said needle.
 38. Thedelivery system of claim 37 further comprising a sleeve locatable aroundsaid needle.
 39. The fastener delivery device of claim 38 wherein saidsleeve further comprises a tissue manipulation element located on adistal end thereof.
 40. The fastener delivery device of claim 38 furthercomprising a sliding track along said needle and wherein said sleevemoves along said sliding track.
 41. The fastener delivery device ofclaim 37 further comprising a slit extending through a side of saidhollow, tubular needle.